FDA Adverse Event
Injury
Summary report: N
GUIDANT VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
MDR report key: 799138
·
Received December 22, 2006
Report
- Report Number
- 3004742046-2006-00549
- Event Type
- Injury
- Date Received
- December 22, 2006
- Date of Event
- November 16, 2006
- Report Date
- December 5, 2006
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- LIT
- PMA / PMN Number
- k020161
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RX ACCULINK, PART# 1011344-30, LOT# 6053151 IS INDICATED IN B5 AND D11, AND IS BEING FILED UNDER MFR REPORT NUMBER 3004742046-2006-00548.
Description of Event or Problem · 1
DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: HYPOTENSION, BRADYCARDIA. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE, POST STENT DEPLOYMENT. IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE LEFT INTERNAL CAROTID ARTERY, THE PT EXPERIENCED PERSISTENT HYPOTENSION POST STENT DEPLOYMENT AND DILATATION. THE PT RECEIVED BLOOD TRANSFUSIONS AND ALL HER BLOOD PRESSURE MEDICATIONS WERE STOPPED. ADDITIONALLY, THE PT EXPERIENCED BRADYCARDIA POST DILATATION, WHICH WAS MEDICALLY MANAGED. SUBSEQUENTLY, BLOOD PRESSURE CAME UP AND THE PT WAS DISCHARGED TO HOME IN 2006 IN STABLE CONDITION. NO ADD'L INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDANT VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER | 74LIT | LIT | GUIDANT ENDOVASCULAR SOLUTIONS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | GUIDE CATHETER: MP 1 8FR| OTHER: RX ACCUNET| STENT: RX ACCULINK| DILATATION CATHETER: FR4 6FR| SHEATH: SUPER SHEATH 8FR| GUIDE WIRE: J WIRES .035 145CM FIXED CORE (X2) |