FDA Adverse Event Malfunction Summary report: N

USCI BAR - TEFLON GUIDE WIRE .035" CM. 3 MM "J"

MDR report key: 9691 · Received July 29, 1994

Report

Report Number: 9691
Event Type: Malfunction
Date Received: July 29, 1994
Date of Event: March 8, 1994
Report Date: July 15, 1994
Manufacturer: BARD USCI
Product Code: DQX
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

3/8/94 PATIENT TO CATH LAB FOR CARDIAC CATHETERIZATION. A "J" GUIDE WIRE WAS PLACED THROUGH RIGHT FEMORAL ARTERY. THE GUIDE WIRE WAS ADVANCED APPROXIMATELY 6". MD HAD DIFFICULTY ADVANCING THE GUIDE WIRE. A 7FR. ARROW HEMOKIT SHEATH WAS PLACED OVER THE GUIDE WIRE IN ORDER TO MAKE A WIRE EXCHANGE. IN THE PROCESS OF MANIPULATING THE SHEATH INTO THE ARTERY, RESISTANCE WAS FELT AND BOTH THE GUIDE WIRE AND SHEATH WERE REMOVED. WHEN THE GUIDE WIRE WAS REMOVED, IT WAS FOUND TO BE BENT AND THE TEFLON COATING WAS PARTIALLY SEPARATED FROM THE WIRE. NOTHING WAS BROKEN OFF THE GUIDE WIRE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	USCI BAR - TEFLON GUIDE WIRE .035" CM. 3 MM "J"	MOVABLE CORE	DQX	BARD USCI		071D0627

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Other