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 2019-01-08 for STONE CONE M0063903200 63445 manufactured by Boston Scientific Corporation.
[132412271]
(b)(6). (b)(4). A stone cone retrieval coil was returned for analysis. A visual analysis of the returned device found that the blue/green heat shrink is pulled away from the distal stop. Furthermore, the coil is kinked at the distal stop. No other anomalies were noted. A functional assessment was performed, and the device was found to be able to open and close freely. It is likely that during unpacking and preparation, the user failed to follow the directions for use by applying excessive force when advancing the blue sheath over the coil, resulting in the coil kinking and the blue/green heat shrink separating from the distal stop. Therefore, the complaint investigation conclusion code selected for this event is failure to follow instructions, which indicates that problems were traced to the user not following the manufacturer's instructions. 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. A labeling review was performed and no anomalies were noted.
Patient Sequence No: 1, Text Type: N, H10
[132412272]
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in a procedure on (b)(6) 2018. According to the complainant, during preparation, it was noticed that the shape of the device changed and the wire seemed to be stretched. The procedure was completed with another stone cone nitinol retrieval coil. There was no serious injury nor were there any adverse patient effects reported as a result of this event. This event has been deemed a reportable event based on the investigation results; coil/cone peeled/shared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-62415 |
| MDR Report Key | 8226827 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-09-03 |
| Date Mfgr Received | 2018-12-19 |
| Device Manufacturer Date | 2017-10-14 |
| Date Added to Maude | 2019-01-08 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | LAKE REGION MEDICAL |
| Manufacturer Street | 1525 HERTZ STREET |
| Manufacturer City | CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONE CONE |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2019-01-08 |
| Returned To Mfg | 2018-09-18 |
| Model Number | M0063903200 |
| Catalog Number | 63445 |
| Lot Number | 0003952318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-08 |