MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-06-07 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903200 390-320 manufactured by Boston Scientific - Marlborough.
[110376964]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). Investigation results: a stone cone nitinol retrieval coil was received for analysis. A visual analysis of the returned device found the coil was tangled on the end preventing it from closing completely. The coil easily untangled and then opened and closed freely. The blue/green heat shrink is pulled away from the distal stop, the core wire is kinked near the marker bands and the two most distal marker bands show signs of wear. The complaint of the device being unable to close and being tangled, was confirmed due to the condition of the returned device. Since the damage occurred during unpacking, the most probable root cause is? Handling damage". The complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Patient Sequence No: 1, Text Type: N, H10
[110376965]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2018. According to the complainant, during unpacking, the device was found to be twisted and was unable to close. 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; coil coating peeled/shared/frayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01784 |
| MDR Report Key | 7578247 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-06-07 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-02-02 |
| Date Mfgr Received | 2018-05-21 |
| Device Manufacturer Date | 2017-07-28 |
| Date Added to Maude | 2018-06-07 |
| 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 |
| 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 | 2018-06-07 |
| Returned To Mfg | 2018-03-05 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | 0003768064 |
| 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 | 2018-06-07 |