FDA Adverse Event Summary report: N

GUIDEWIRE

MDR report key: 25632 · Received January 10, 1995

Report

Report Number: 25632
Date Received: January 10, 1995
Report Date: December 31, 1994
Manufacturer: MEDITECH/BOSTON SCIENTIFIC CORP.
Product Code: MKI
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

DURING ARTERIOGRAM, GUIDEWIRE DID NOT ADVANCE EASILY, BUT THEN PASSED THRU. NEEDLE REMOVED AND SHEATH PLACED WITH DIFFICULTY OVER WIRE. DILATOR REMOVED FROM SHEATH. WHEN WIRE REMOVED, IT WAS NOTED THAT COATING WAS MISSING STARTING APPROX. 8" FROM J-TIP TO CURVE OF J ON WIRE.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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID 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	GUIDEWIRE		MKI	MEDITECH/BOSTON SCIENTIFIC CORP.	46-151	8894E26

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Invalid Data