MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-16 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903100 390-310 manufactured by Boston Scientific - Marlborough.
[77834268]
(b)(4). A visual analysis of the returned device found the device was returned in one piece. The core wire pulled out when trying to close the device. Furthermore, the core wire was broken into two pieces. The blue sheath and white heat shrink were found accordion. Moreover, the white shrink was torn. In addition, the blue/ green shrink was pulled away from distal stop. Evaluation concluded that the broken core wire most likely caused by the lithotripter during the procedure. Therefore, the most probable root cause for this complaint event is caused by other device. A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.
Patient Sequence No: 1, Text Type: N, H10
[77834269]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a ureterolithotomy procedure on (b)(6) 2017. According to the complainant, during the procedure, the handle end of the blue sheath accordioned when attempting to close the device. The coil failed to close and there was difficulty removing the device from the ureter. Device was disassembled and was removed from the patient. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable. This event has been deemed a reportable event based on the investigation results; core wire broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-01763 |
| MDR Report Key | 6649024 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-16 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-03-28 |
| Date Mfgr Received | 2017-05-23 |
| Device Manufacturer Date | 2015-05-08 |
| Date Added to Maude | 2017-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | ACCELLENT ENDOSCOPY JUAREZ |
| Manufacturer Street | 31C BUTTERFIELD TRAIL |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2017-06-16 |
| Returned To Mfg | 2017-04-19 |
| Model Number | M0063903100 |
| Catalog Number | 390-310 |
| Lot Number | D86221 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-16 |