FDA Adverse Event
Injury
Summary report: N
PERFORMER BALKIN GUIDING SHEATH
MDR report key: 1193563
·
Received September 23, 2008
Report
- Report Number
- 1820334-2008-00525
- Event Type
- Injury
- Date Received
- September 23, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 26, 2008
- Manufacturer
- COOK INC.
- Product Code
- DYB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
DURING A RIGHT FEMORAL ARTERY PROCEDURE FOR DISTAL LEFT SCA STENOSIS LESION, THE PHYSICIAN WAS PLACING A SHEATH INTO THE RIGHT FEMORAL ARTERY. THE LESION WAS WIRED WITH ANOTHER MFR'S .035 WIRE, PREDILATED WITH ANOTHER MFR'S BALLOON CATHETER FOLLOWED BY ANOTHER BALLOON CATHETER. THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER MFR'S STENT BUT WAS UNABLE TO PASS THE STENT. A STIFF WIRE WAS PLACED AFTER EXCHANGING THE WIRE ALREADY IN PLACE. A NEW STENT WAS PLACED AND DEPLOYED. UPON THE STENT CATHETER REMOVAL, THE INTRODUCER SHEATH SEPARATED AT THE VALVE AND SHEATH. THE SHEATH WAS UNABLE TO BE RETRIEVED SO THE PT HAD TO BE TAKEN TO ANOTHER LARGER FACILITY FOR THE PIECE TO BE SURGICALLY REMOVED VIA CUTDOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERFORMER BALKIN GUIDING SHEATH | DYB INTRODUCER, CATHETER | DYB | COOK INC. | NA | F1932892 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |