BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 4111353 · Received September 23, 2014

    Report

    Report Number
    9616099-2014-00621
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K112797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED, AN 80 CM. POWERFLEX-PRO 8 MM. X 4 CM. BALLOON CATHETER (BC) RUPTURED AT SIX ATMOSPHERES (6 ATM.) DURING THE INITIAL INFLATION. THE BC WAS USED TO POST-DILATE A SMART CONTROL STENT THAT WAS JUST DEPLOYED. THE BC WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANOTHER POWERFLEX-PRO 8 X 40 BC WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE RIGHT ILIAC ARTERY. THE LESION WAS REPORTED TO BE HEAVILY CALCIFIED, MODERATELY TORTUOUS WITH 90% STENOSIS. THE APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY WITH A NON-CORDIS GUIDING SHEATH. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF LOT 16098324 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED BALLOON BURST AT/BELOW RBP COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (CALCIFICATION, TORTUOSITY AND STENOSIS) MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON BURST. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGESTS THAT THE BALLOON BURST COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT AN 80 CM. POWERFLEXPRO 8 MM. X 4 CM. BALLOON CATHETER (BC) RUPTURED AT SIX ATMOSPHERES (6 ATM.) DURING THE INITIAL INFLATION. THE BC WAS USED TO POST-DILATE A SMART CONTROL STENT THAT WAS JUST DEPLOYED. THE PRODUCT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANOTHER POWERFLEXPRO 8 X 40 BC WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE RIGHT ILIAC ARTERY. THE LESION WAS REPORTED TO BE: HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND A 90% STENOSIS. THE APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY WITH A NON-CORDIS GUIDING SHEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590354 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 16098324

    Patients

    Seq Age Sex Outcome Treatment
    1 CSI: 6FR PARENT, MEDIKIT