MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for AMPLATZ SUPER STIFF 39575 manufactured by Boston Scientific Corporation.
[187464172]
Date of event: the end of february.
Patient Sequence No: 1, Text Type: N, H10
[187464173]
It was reported that guidewire detachment occurred. The target lesion was located in the hepatic artery. A 035/145 amplatz super stiff guidewire was used to cross the lesion. However, after 2-3 minutes of maneuvering the wire, it was lodged in the catheter and the spring tip uncoiled. The outer coil 'let go' and was difficult to pull back. When the device was removed and inspected, it was noted that the inside of the wire was dislodged. No known patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03790 |
| MDR Report Key | 9882552 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-26 |
| 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 | 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 | 2020-03-26 |
| Model Number | 39575 |
| Catalog Number | 39575 |
| Lot Number | 0023738492 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2020-03-26 |