FDA Adverse Event
Injury
Summary report: N
LUNDERQUIST
MDR report key: 17488368
·
Received August 9, 2023
Report
- Report Number
- MW5121067
- Event Type
- Injury
- Date Received
- August 9, 2023
- Report Date
- December 1, 2022
- Manufacturer
- COOK MEDICAL LLC
- Product Code
- DQX
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PROCEDURE WAS CONVERTED TO SURGERY. A LEFT VENTRICLE PERFORATION WAS NOTED. PER THE PHYSICIAN, A LUNDERQUIST GUIDEWIRE WAS THE CAUSE OF THE LEFT VENTRICLE PERFORATION. A REPAIR WAS PERFORMED BY A CARDIAC SURGEON. THE PATIENT WAS STABLE AND IN RECOVERY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1683471 | LUNDERQUIST | WIRE, GUIDE, CATHETER | DQX | COOK MEDICAL LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |