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 2019-02-26 for STONE CONE M0063903200 390-320 manufactured by Boston Scientific Corporation.
[137157829]
(b)(4). Investigation results: a stone cone retrieval coil was returned for analysis. A visual analysis of the returned device found that the blue/green heat shrink at the distal tip is detached from/not flush with the distal stop. No other damages were noted to the blue sheath, white heat shrink, or coil. There were no kinks noted along the working length of the nitinol core wire. The distal stop was not overridden. A functional assessment was performed. The device functioned as intended. There were no issues noted with opening or closing of the coil. For the failure found of blue/green heat shrink at the distal tip found detached from/not flush with the distal stop, and based on all gathered information, the complaint investigation conclusion code selected for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event. 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
[137157830]
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter for a upper ureteroscope stone procedure performed on (b)(6) 2018. According to the complainant, during procedure, it was noticed that the stone cone couldn't be open. 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 | 3005099803-2019-00951 |
| MDR Report Key | 8369961 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2019-02-03 |
| Device Manufacturer Date | 2017-12-06 |
| Date Added to Maude | 2019-02-26 |
| 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 | 2019-02-26 |
| Returned To Mfg | 2018-12-20 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | 0004023644 |
| 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 | 2019-02-26 |