FDA Adverse Event
Malfunction
Summary report: N
GUIDE WIRE 0.018"PTFE COATED
MDR report key: 23936288
·
Received December 31, 2025
Report
- Report Number
- 1220648-2025-49705
- Event Type
- Malfunction
- Date Received
- December 31, 2025
- Date of Event
- September 22, 2025
- Report Date
- February 17, 2026
- Manufacturer
- ABIOMED, INC.
- Product Code
- NKQ
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
B5 UPDATED.
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED. LOGS ARE NOT APPLICABLE. THE CAUSE OF THE GUIDEWIRE KINK WAS USE RELATED SINCE THE 0.018 GUIDEWIRE WAS LEFT IN THE PUMP WHEN STARTING IT.
Description of Event or Problem · 0
THE COMPLAINANT REPORTED ADDITIONAL INFORMATION UPON REQUEST: "THE IMPELLA 5.5 HAD NO ISSUES AFTER THE INITIAL INSERTION. NO REPLACEMENT OF PUMP WAS NEEDED. THE DEVICE WAS DISPOSED AND NO OTHER INFORMATION IS AVAILABLE!".
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING IMPLANTATION OF AN IMPELLA 5.5 THERE WAS A PUMP STOP THAT PROMPTED THE PUMP TO BE REMOVED, REFLUSHED AND PLACED. THE WIRE WAS OBSERVED TO BE DAMAGED UPON REMOVAL/REPLACEMENT. LATER, THE PATIENT WAS SUCCESSFULLY WEANED FROM THE PUMP AND SURVIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 588308 | GUIDE WIRE 0.018"PTFE COATED | GUIDEWIRE, CATHETER | NKQ | ABIOMED, INC. | GUIDE WIRE 0.018"PTFE COATED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male |