FDA Adverse Event
Injury
Summary report: N
VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM
MDR report key: 1202866
·
Received October 17, 2008
Report
- Report Number
- 2953148-2008-00860
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 29, 2008
- Report Date
- September 29, 2008
- Manufacturer
- GUIDANT CARDIAC SURGERY
- Product Code
- GEI
- PMA / PMN Number
- K052274
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED.
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TIP OF THE SILICONE JAW BROKE OFF INSIDE THE TUNNEL. THE BROKEN TIP WAS RETRIEVED THROUGH THE ORIGINAL INCISION USING THE HEMOPRO JAW FROM THE REPLACEMENT DEVICE. THE REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | GUIDANT CARDIAC SURGERY | VH-3000 | 8070171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |