FDA Adverse Event
Injury
Summary report: N
GUIDANT VASOVIEW 6 HARVESTING CANNULA
MDR report key: 633165
·
Received September 1, 2005
Report
- Report Number
- 2953148-2005-00696
- Event Type
- Injury
- Date Received
- September 1, 2005
- Date of Event
- July 24, 2005
- Report Date
- August 22, 2005
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- GEI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING THE SAPHENOUS VEIN HARVESTING PROCEDURE, THE DEVICE HAD SLIDING PROBLEM. NO OTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. UPON RECEIPT ON AUGUST 25, 2005, THE DEVICE WAS RECEIVED WITH THE C-RING DETACHED FROM THE HARVESTING CANNULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT VASOVIEW 6 HARVESTING CANNULA | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACE | GEI | GUIDANT CARDIAC SURGERY | VH-2000 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |