BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM PTA DILATATION CATHETER

    MDR report key: 1023550 · Received March 31, 2008

    Report

    Report Number
    9610978-2008-00085
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICALLY USED SLALOM THRILL BALLOON CATHETER WAS RECEIVED FOR ANALYSIS. A .014" GUIDEWIRE WAS STILL INSERTED IN THE GUIDEWIRE LUMEN. THE DISTAL TIP WAS FOUND ON THE WIRE AND WAS SEPARATED FROM THE CATHETER. THE GUIDEWIRE WAS KINKED AND TWISTED AND HAD PENETRATED THE DISTAL TIP OF THE CATHETER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. A 0.18" CORDIS GUIDE WIRE COULD BE ADVANCED THROUGH THE GUIDE WIRE LUMEN WITHOUT ANY DIFFICULTY. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACES REVEALED EVIDENCE OF A GOOD DISTAL SEAL. THE FRACTURE SURFACES SHOW EVIDENCE OF STRETCHING INDICATING THAT A PULL FORCE WAS APPLIED RESULTING IN THE TIP SEPARATION. IT APPEARS THAT THE DISTAL TIP GOT CAUGHT ON THE WIRE DUE TO THE TWIST IN THE GUIDE WIRE. SUBSEQUENTLY, THE TWISTED GUIDE WIRE PENETRATED THE DISTAL TIP AND ULTIMATELY THE DISTAL TIP SEPARATED DURING MANIPULATION OR WITHDRAWAL BY THE PHYSICIAN. THEREFORE, THIS COMPLAINT IS CONSIDERED PROCEDURE RELATED. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY DEVICE INTERACTION ALONG WITH THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE. THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES, BUT IS SIMILAR TO US DISTRIBUTED PTA SYSTEMS.

    Description of Event or Problem · 1

    WHILE ADVANCING THE BALLOON CATHETER OVER THE GUIDEWIRE TOWARDS AN UNDESCRIBED LESION IN A DIALYSIS SHUNT, IT BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN ATTEMPTED TO ADVANCE IT FURTHER, HOWEVER THE DISTAL TIP APPEARED TO BE BROKEN, WITH SEPARATION OF THE DISTAL TIP. THE PHYSICIAN REMOVED THE GUIDEWIRE, THE BALLOON AND THE SHEATH INTRODUCER TOGETHER AS ONE UNIT. THE PHYSICIAN WAS NOT ABLE TO CONFIRM THE COMPLETE SEPARATION OF THE TIP, AND NOTHING REMAINED IN THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM PTA DILATATION CATHETER PTA CATHETERS LIT CORDIS EUROPA, N.V. NA R0705061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 0.014" GUIDEWIRE (CRUISE