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 2020-03-24 for AMPLATZ SUPER STIFF 39575 manufactured by Boston Scientific Corporation.
[184808653]
Device evaluated by mfr: unit returned with its original pouch and together with a non-boston scientific catheter. Overall visual examination did not identify failures or evidence that could be lost due to decontamination process. The guidewire returned inside of a non-boston scientific device. The non-bsc device had a metallic cannula. The guidewire was easily removed from the non-bsc device. The guidewire was kinked near the distal end; besides, where the kinked section was located, the coating of the guidewire was damaged (peeled). The guidewire was not unraveled. Outer diameter of distal tip, middle of the device and the proximal section are within specifications. Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Patient Sequence No: 1, Text Type: N, H10
[184808714]
Reportable based on device analysis completed on 06mar2020. It was reported that guidewire unravel issue occurred. A st/035/145 (bx/5) amplatz super stiff guidewire was selected for use but the guidewire unraveled while exchanging a drain catheter. The procedure was completed with a different device. There were no patient complications reported. However, returned device analysis revealed coating peeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03560 |
| MDR Report Key | 9871928 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-08-28 |
| Date Added to Maude | 2020-03-24 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 302 PARKWAY, GLOBAL PARK |
| Manufacturer City | LA AURORA - HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZ SUPER STIFF |
| Generic Name | WIRE, GUIDE, CATHETER |
| Product Code | DQX |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-02-20 |
| Model Number | 39575 |
| Catalog Number | 39575 |
| Lot Number | 0024343776 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |