FDA Adverse Event Malfunction Summary report: N

7F STANDARD ATHEROCATH/SUPPORT GUIDEWIRE

MDR report key: 9289 · Received July 29, 1994

Report

Report Number: 9289
Event Type: Malfunction
Date Received: July 29, 1994
Report Date: July 11, 1994
Manufacturer: DVI/ACS (GUIDEWIRE)
Product Code: MKI
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

MD ATTEMPTED TO ADVANCE WIRE AND PULL ATHEROCATH BACK. WIRE WOULD NOT ADVANCE. PULLED WIRE AND ATHEROCATH OUT. ATTEMPTED TO REMOVE WIRE-UNABLE TO REMOVE FROM EITHER END OF ATHEROCATH.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	7F STANDARD ATHEROCATH/SUPPORT GUIDEWIRE	ATHEROCATH/GUIDEWIRE	MKI	DVI/ACS (GUIDEWIRE)		140471/4050951

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other