FDA Adverse Event Malfunction Summary report: N

JR4

MDR report key: 1883460 · Received October 12, 2010

Report

Report Number
1883460
Event Type
Malfunction
Date Received
October 12, 2010
Date of Event
September 29, 2010
Report Date
September 29, 2010
Manufacturer
CORDIS
Product Code
DYB
Product Problem
Yes
Report Source
User Facility report
Reporter Location
SC, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A CORDIS 6 FRENCH JR4 GUIDING CATHETER WAS UTILIZED TO PERFORM AN INTERVENTION INVOLVING A LESION IN A RIGHT CORONARY ARTERY. THE CATHETER SEATED WELL INTO THE RCA, AND AN ANGIOPLASTY WAS PERFORMED WITHOUT DIFFICULTY. THE PHYSICIAN THEN ATTEMPTED TO STENT THE LESION. THE STENT WOULD NOT PASS THROUGH THE GUIDING CATHETER. THE STENT WOULD NOT PASS THE "HUB" OF THE CATHETER IN THE AREA WHERE THE "WINGS" ARE LOCATED. SUBSEQUENTLY, THE STENT WAS REMOVED FROM THE WIRE INTACT, THE GUIDE WIRE REMOVED, THE CATHETER REMOVED, AND THE SAME SIZE CATHETER FROM A DIFFERENT VENDOR WAS UTILIZED. THE SAME PREVIOUS STENT WAS PASSED THROUGH THE SECOND CATHETER, AND THE STENT WAS DEPLOYED SUCCESSFULLY. THE POTENTIAL FOR INJURY, AND NEGATIVE OUTCOME, COMES FROM HAVING TO LOSE THE INTERVENTIONAL WIRE POSITION ACROSS THE LESION IN ORDER TO EXCHANGE THE GUIDING CATHETER.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SUCCESSFUL STENTING WAS ACHIEVED. THE POTENTIAL FOR ADVERSE OUTCOME IS NOTED ABOVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 JR4 INTRODUCER, CATHETER DYB CORDIS 6F JR4 .070 I.D. 15206105

Patients

Seq Age Sex Outcome Treatment
1 69 YR