FDA Adverse Event Injury Summary report: N

SCI MED ACE 3.0

MDR report key: 2781 · Received February 1, 1993

Report

Report Number: 2781
Event Type: Injury
Date Received: February 1, 1993
Date of Event: October 9, 1992
Report Date: December 9, 1992
Manufacturer: SCI MED LIFE SYSTEMS, INC.
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PATIENT TO CATH LAB (10/19/92) FOR PTCA. POST-PROCEDURE (10/22/92) PATIENT WITH CHEST PAIN. RETURNED TO CATH LAB (10/23/92). AGAIN TO CATH LAB (10/24/92). PATIENT TAKEN TO OR FOR CABG X2; ONE PIECE OF THREE PIECE PLASTIC SHEATH OF PTCA BALLOON CATHETER WAS REMOVEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: DESIGN - INADEQUATE. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER, NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SCI MED ACE 3.0	SCI MED PTCA DILATATION CATHETER		SCI MED LIFE SYSTEMS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention