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 2018-02-13 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903200 390-320 manufactured by Boston Scientific - Marlborough.
[100148311]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). A visual analysis of the returned device, found that it was returned- approximately half open/closed. The blue sheath was pulled back to expose the coil. The coil was in its intended shape. The blue/green heat shrink is damaged near the distal end of the coil. As a result of the damages, the device opens freely but will not close completely. 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. The device history record (dhr) review found the device met all manufacturing specifications.
Patient Sequence No: 1, Text Type: N, H10
[100148312]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2017. According to the complainant, during unpacking, the stone cone nitinol urological retrieval coil was opened and it was found that the coil was not in its regular shape. The procedure was completed with another stone cone nitinol urological retrieval coil. 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 an mdr-reportable event based on investigation results which revealed that the coil/cone coil coating peeled/shared/frayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00259 |
| MDR Report Key | 7267631 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-13 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2017-04-03 |
| Date Added to Maude | 2018-02-13 |
| 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 | 2018-02-13 |
| Returned To Mfg | 2018-01-02 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | G35698 |
| 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 | 2018-02-13 |