FDA Adverse Event
Injury
Summary report: N
FLEXOR TM CHECK-FLO TM II INTRODUCER SET
MDR report key: 1073670
·
Received July 9, 2008
Report
- Report Number
- 1820334-2008-00350
- Event Type
- Injury
- Date Received
- July 9, 2008
- Report Date
- June 11, 2008
- Manufacturer
- COOK, INC.
- Product Code
- DYB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE PHYSICIAN WAS USING THE SHEATH TO DO A SFA GRAFT REPAIR. THE PHYSICIAN ADVANCED THE SHEATH AND DID HIS WORK AND THEN AS HE BEGAN TO PULL IT BACK, THE SHEATH BROKE IN HALF. HE SAID HE DID NOT STRETCH IT AND THAT HE DID NOT FEEL IT BEING STRETCHED IN ANY WAY. THE PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE SEPARATED SEGMENT. THE PT IS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXOR TM CHECK-FLO TM II INTRODUCER SET | DYB INTRODUCER, CATHETER | DYB | COOK, INC. | NA | 2079813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |