FDA Adverse Event
Malfunction
Summary report: N
GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL
MDR report key: 483731
·
Received September 10, 2003
Report
- Report Number
- 2953148-2003-00926
- Event Type
- Malfunction
- Date Received
- September 10, 2003
- Report Date
- August 19, 2003
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- DXC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TWO HEARTSTRING SEALS WERE RECEIVED BY GUIDANT CARDIAC SURGERY ON 8/19/2003. ONE SEAL WAS RECEIVED CRACKED AND THE DEPLOYMENT TUBE IS BENT. THE SECOND SEAL IS CRACKED AND UNRAVELED FROM THE END. NO OTHER INFO WAS REPORTED BY THE DISTRIBUTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL | VASCULAR CLAMP | DXC | GUIDANT CARDIAC SURGERY | HS-1045 | 3020482 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |