FDA Adverse Event Death Summary report: N

N/A

MDR report key: 577 · Received January 21, 1992

Report

Report Number: 577
Event Type: Death
Date Received: January 21, 1992
Date of Event: December 13, 1991
Report Date: January 3, 1992
Manufacturer: ARROW INTERNATIONAL, INC
Product Code: DYB
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

THE CATHETER PLACED IN PREPARATON FOR SURGERY HAD BEEN INADVERTENTLY PLACED IN SUCH A WAY THAT IT WAS ABLE TO INJURE THE WALL OF THE HEART. THIS PRODUCED A PERFORATION WHICH ALLOWED BLOOD TO LEAK OUTSIDE THE HEART AND LEAD TO THE CARDIAC ARREST THAT THE PATIENT EXPERIENCED ON THE MORNING FOLLOWING THE SURGERYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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. NO 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE, INHERENT RISK OF PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: INVALID DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	N/A	PERCUTANEOUS SHEATH INTRODUCER KIT	DYB	ARROW INTERNATIONAL, INC	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	11 YR		Death