FDA Adverse Event
Summary report: N
CATH-SEAL PC1 WITH 3-WAY STOP COCK
MDR report key: 26432
·
Received July 27, 1995
Report
- Report Number
- 26432
- Date Received
- July 27, 1995
- Manufacturer
- UNIVERSAL MEDICAL INSTRUMENT CORP.
- Product Code
- DYB
- Report Source
- User Facility report
Narratives
Description of Event or Problem · 1
WHILE REMOVING THE GUIDING CATHETER, THE CLEAR PORTION OF THE LONG SHEATH (THE SIDE ARM WITH 3-WAY STOP COCK) SEPARATED FROM THE SHEATH IN THE FEMORAL ARTERY. THE REMAINDER OF THE SHEATH HAD TO BE EXCHANGED OVER THE GUIDE WIRE AND A NEW SHEATH INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CATH-SEAL PC1 WITH 3-WAY STOP COCK | CATH-SEAL PC1 WITH 3-WAY STOP COCK | DYB | UNIVERSAL MEDICAL INSTRUMENT CORP. | 1200903030 | 150276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |