FDA Adverse Event Injury Summary report: N

INTEGRIS BIPLANE

MDR report key: 740940 · Received July 14, 2006

Report

Report Number
740940
Event Type
Injury
Date Received
July 14, 2006
Date of Event
May 22, 2006
Report Date
July 10, 2006
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC
Product Code
IZI
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AL, US

Narratives

Description of Event or Problem · 1

PHYSICIAN WAS ADVANCING GUIDEWIRE FOR ANGIOPLASTY INTERVENTION WHEN EQUIPMENT FAILURE OCCURRED & GUIDEWIRE PERFORATED CORONARY ARTERY. RELEVANT INFORMATION PRIOR TO ACTUAL EVENT:CATH LAB CALL TEAM WAS CALLED IN FOR AN EMERGENCY PROCEDURE IN EARLY A.M. HOURS OF THE DAY OF THE EVENT. DURING PROCEDURE THE IMAGING/X-RAY EQUIPMENT MONITORS FLICKERED AND CINEFLUOROGRAPHY TEMPORARILY STOPPED WORKING. THE REGISTERED RADIOGRAPHER ON CALL TEAM ASKED PHYSICIAN TO TEMPORARILY STOP PROCEDURE. THE IMAGING EQUIPMENT WAS TURNED OFF FOR A SHORT INTERVAL, THEN BACK ON. WHEN THE EQUIPMENT CAME BACK ONLINE ALL SYSTEMS SEEMED TO BE WORKING AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. EVENT:WORKDAY BEGAN - STAFF ASSIGNED TO LAB WAS UNAWARE OF EARLY A.M. MALFUNCTION. 1ST CASE PT WAS BROUGHT TO ROOM AND PREPARED FOR LEFT HEART CATHETERIZATION(LHC) WITH POSSIBLE PERCUTANEOUS CORONARY INTERVENTION(PCI). PHYSICIAN PERFORMED THE DIAGNOSTIC CATH. DETERMINED PATIENT NEEDED AN INTERVENTION (ANGIOPLASTY WITH STENT PLACEMENT). PHYSICIAN PROCEEDED WITH PROCEDURE. THE INTERVENTIONAL GUIDEWIRE WAS INSERTED AND ADVANCED INTO THE CORONARY ARTERY, THE IMAGING EQUIPMENT FLICKERED AND BLINKED. THE EQUIPMENT WAS RE-BOOTED. WHEN IMAGING EQUIPMENT CAME BACK ONLINE THE IMAGES WERE STILL VISIBLE; HOWEVER THE IMAGE QUALITY SEEMED TO BE SOMEWHAT DEGRADED. STAFF IN THE PROCEDURE ROOM STATED IMAGES ON MONITOR WERE OF POOR QUALITY AND VISUALIZATION WAS DIFFICULT. THE STAFF REPORTED THE GUIDEWIRE THAT HAD PREVIOUSLY BEEN ADVANCED INTO THE CORONARY ARTERY COULD HAVE INADVERTENTLY CAUSED A PERFORATION OF THE CORONARY ARTERY DURING THE TIME THE EQUIPMENT MALFUNCTIONED ADVANCING GUIDEWIRE FOR ANGIOPLASTY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INTEGRIS BIPLANE X-RAY SYSTEM, CARDIAC CATH IZI PHILIPS MEDICAL SYSTEMS, INC VH-300 *

Patients

Seq Age Sex Outcome Treatment
1 69 YR