BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 1942445 · Received December 30, 2010

    Report

    Report Number
    9610978-2010-00267
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 13, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE AN OPTAPRO BALLOON HAD A PUNCTURE IN THE SHAFT OF THE DEVICE. THE PATIENT IS A (B)(6) MALE. THE PROCEDURE BEING PERFORMED WAS AN ANGIOPLASTY PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED. THERE WAS NO DIFFICULTY FLUSHING THE DEVICE. THERE WAS NO DIFFICULTY TRACKING THE DEVICE TO THE TARGET LESION. THE REPORTER STATES THAT THE PHYSICIAN COULD NOT INFLATE THE BALLOON SO HE SUSPECTED A HOLE IN THE SHAFT. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER OPTAPRO BALLOON WAS USED TO TREAT THE LESION. THERE WAS NO REPORTED INJURY TO THE PATIENT. A NON STERILE OPTA PRO 5.0MMX10CM, 80CM WAS RECEIVED COILED AND INSIDE A BAG. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED, THE SHAFT PRESENTS ONE CUT AT 31 CM 32 CM FROM THE DISTAL TIP, THIS CUT COULD BE DONE BY BLADE TOOL. NO ANOMALIES WERE NOTED IN THE RETURNED DEVICE. AN ATTEMPT TO INFLATE THE BALLOON WAS DONE, AND DURING GW LUMEN FLUSHING TEST IT COULD BE NOTED THE SHAFT LEAKING IN THE CUT AREA. IT WAS PROCEEDED TO INFLATE THE BALLOON FOLLOWING THE MENTIONED DP AND THE BALLOON COULD BE INFLATED WITHOUT DIFFICULTY. THE RECEIVED UNIT WAS REVIEWED WITH THE PET TEAM OF THE AREA IN ORDER TO REPRODUCE THE FAILURE IN THE SLEEVE REMOVAL PROCESS. IN THE PROXIMAL SEAL STATION IS REMOVED THE SEAL SLEEVE OF THE SHAFT USING THE SLEEVE REMOVAL TOOL. THE ANALYSIS PROCEDURE SHOWS THE STEPS TO PLACE TO SEAL SLEEVE UNIT FOR THE REMOVAL, HOWEVER IF THE SEAL SLEEVE IS NOT PLACED CORRECTLY IN THE DESIGNATED AREA OF THE PRODUCTION TABLE, SOMETIMES THE SHAFT CAN BE DAMAGED BY THE BLADE. A 100% INSPECTION IS DONE TO DETECT SHAFT DAMAGE CAUSED BY THE REMOVAL PROCESS. AN OPTA PRO SCRAP UNIT WAS TAKEN IN ORDER TO REPRODUCE THE SHAFT DAMAGE FAILURE AND AFTER SEVERAL ATTEMPTS A SIMILAR FAILURE COULD BE REPRODUCE. THE UNIT WAS TAKEN TO THE SEM LABORATORY AND SHOWED THAT THE SHAFT PRESENTS A DAMAGE THAT WENT THROUGH THE WHOLE WALL THICKNESS OF THE OUTER BODY. THE EXACT CAUSE OF THE FAILURE MODE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT APPEARS THAT A SHARP OBJECT DAMAGED THE OUTER BODY EXTERNALLY. ASSOCIATES FROM PRO/PFP3/EXTREME LINES WERE NOTIFIED REGARDING SHAFT DAMAGE (HOLE) COMPLAINT RECEIVED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE BODY/SHAFT PUNCTURE/CUT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE EXACT CAUSE OF THE SHAFT DAMAGE OCCURRED DURING THE USE OF THE SEAL SLEEVE REMOVAL TOOL, IF THE SEAL SLEEVE IS NOT PLACED CORRECTLY IN THE DESIGNATED AREA OF THE PRODUCTION TABLE, SOMETIMES THE SHAFT CAN BE DAMAGED BY THE BLADE. A 100% INSPECTION IS DONE TO DETECT DAMAGE IN THE SHAFT CAUSED BY THE REMOVAL PROCESS. A DPRA WAS OPENED TO ADDRESS THIS COMPLAINT. THE REPORTED COMPLAINT WAS CONFIRMED ON ANALYSIS AND POSSIBLY RELATED TO THE MANUFACTURING PROCESS. RISK ASSESSMENT PROCEDURES HAVE BEEN INITIATED TO ADDRESS THE CONFIRMED FAILURE MODE IN THIS PRODUCT FAMILY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE DOCTOR COULD NOT INFLATE THE BALLOON BECAUSE OF A HOLE IN THE SHAFT. THE PATIENT IS A (B)(6) MALE. THE PROCEDURE BEING PERFORMED WAS AN ANGIOPLASTY PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15091661

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR