FDA Adverse Event Injury Summary report: N

INTREPID PTCA CATHETER - 2.00 MM BALLOON SIZE

MDR report key: 4545 · Received July 23, 1992

Report

Report Number: 4545
Event Type: Injury
Date Received: July 23, 1992
Date of Event: December 4, 1991
Report Date: July 23, 1992
Manufacturer: EDWARDS LIS DIVISION - BAXTER HEALTHCARE CORPORATION
Product Code: LIT
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ON 12/4/91, DURING A PTCA PROCEDURE OF A DIAGNAL BRANCHOFTHELAD A PIN HOLE LEAK OCCUREDITHECATHETER AT 4 ATM ON THESECOD INFLATION. A DISSECTION OCCURRED. THE PATIENT WAS TAKEN TO THE O.R. FOR EMERGENCY BYPASS SURGERY. MFG. NOTIFIED ON 12/4/92INVALID 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. 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	INTREPID PTCA CATHETER - 2.00 MM BALLOON SIZE		LIT	EDWARDS LIS DIVISION - BAXTER HEALTHCARE CORPORATION	72-SL4-2.0

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention