| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01141-1 |
| Product Name/Description |
Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract)
Catalogue Numbers: 250-227, 250-228 and 250-229
Material Numbers: M0062502270, M0062502280 and M0062502290
Multiple Lot Numbers affected
ARTG Number: 126446 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has received reports from the field that the tip of the dilator has separated from the body of the dilator during procedure. If the tip broke off as the shaft was being advanced near the ureteopelvic junction (UPJ), then inadvertent blunt trauma to the renal parenchyma or renal hilar vessels could occur. This could produce anything from a small haematoma up to haemorrhage requiring medical therapy (transfusion), radiologic intervention (embolisation) or surgery (nephrectomy). However, in most cases the attempted removal of the tip would result in a second intervention. Unless the tip fell off in the packaging or at placement over the guidewire the defect is unlikely to be detected prior to the procedure. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific are requesting users to inspect current stock and quarantine affected batches. Affected product can be returned to Boston Scientific for replacement or a credit note. |
| Contact Information |
02 8063 8340 - Boston Scientific Quality Assurance |