FDA Adverse Event Injury Summary report: N

GUIDEWIRE FROM CV CATHETER KIT

MDR report key: 20905 · Received August 29, 1994

Report

Report Number: 20905
Event Type: Injury
Date Received: August 29, 1994
Date of Event: June 6, 1994
Report Date: July 26, 1994
Manufacturer: ABBOTT CRITICAL CARE SYSTEMS
Product Code: MKI
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

THE PATIENT, A 70 YEAR OLD MALE, WAS ADMITTED WITH A DIAGNOSIS OF SMALL BOWEL OBSTRUCTION. DURING INSERTION OF A GUIDEWIRE, FOR THE PURPOSE OF INSERTING A CVP CATHETER, THE GUIDEWIRE WOULD NOT ADVANCE. UPON REMOVAL OF THE QUIDEWIRE IT WAS NOTED THAT A FINE WIRE, WHICH SEEMED TO SECURE, THE "COILS" OF THE WIRE WAS BROKEN. PATIENT TOLERATED PROCEDURE WELL.PRODUCT WAS GIVEN TO THE MANUFACTURER FOR QA TESTING.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 FROM CV CATHETER KIT		MKI	ABBOTT CRITICAL CARE SYSTEMS	LIST# 41401-04-01	86-062-SN

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Required Intervention