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 2017-10-05 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903200 390-320 manufactured by Boston Scientific - Marlborough.
[89433357]
(b)(4). A visual analysis of the returned device revealed that the coil is tangled at the distal end. The device opened completely but only closed up to where the coil was tangled. There is a slight bend in the device near the distal marker bands. The blue green shrink is pulled away from the distal stop. Moreover, the coil was untangled by hand and the device opened and closed freely. Review and analysis of all available information indicates that the complaint was caused by handling damage 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. Therefore, the most probable root cause is "handling damage". The device history record (dhr) review found the device met all manufacturing specifications. A search of the complaint database revealed that no similar complaints exist for the specified lot.
Patient Sequence No: 1, Text Type: N, H10
[89433358]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a transurethral ureterolithotripsy (tul) procedure performed on (b)(6) 2017. According to the complainant, during the preparation, device was tested by opening and closing and the coil was noted to be entangled. 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 "good". Note: 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 | 3005099803-2017-02936 |
| MDR Report Key | 6918392 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-05 |
| Date of Report | 2017-09-17 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2017-09-17 |
| Device Manufacturer Date | 2016-05-06 |
| Date Added to Maude | 2017-10-05 |
| 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 | 2017-10-05 |
| Returned To Mfg | 2017-08-22 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | F16006 |
| Device Expiration Date | 2019-03-07 |
| 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 | 2017-10-05 |