FDA Adverse Event
Malfunction
Summary report: N
GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL
MDR report key: 483725
·
Received September 10, 2003
Report
- Report Number
- 2953148-2003-00925
- 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. THERE WAS NO PT INVOLVEMENT REPORTED.
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 | 3020481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |