BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 3883694 · Received June 19, 2014

    Report

    Report Number
    9616099-2014-00388
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K112797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE 80 CM. POWERFLEXPRO 7 MM. X 4 CM. BALLOON CATHETER (BC) RUPTURED AT SEVEN ATMOSPHERES (7 ATM.) DURING THE INITIAL INFLATION. CONTRAST LEAKAGE WAS NOTED. THE PRODUCT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANOTHER BC WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE ILIAC ARTERY. TARGET LESION CHARACTERISTIC INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION PRIOR TO USE. THERE WAS NO INFORMATION PROVIDED REGARDING CONTRAST OR THE CONTRAST TO SALINE RATIO USED. AN UNKNOWN INFLATION DEVICE WAS USED FOR THE PROCEDURE AND WAS USED SUBSEQUENTLY WITH OTHER DEVICES. THERE WAS NO REPORTED DIFFICULTY OR RESISTANCE/FRICTION REPORTED DURING ADVANCEMENT THROUGH THE GUIDING CATHETER OR ACCESSING THE LESION. THERE WAS NO REPORTED DIFFICULTY ACCESSING THE TARGET LESION AND THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE CATHETER DID NOT KINK DURING USE. THE CATHETER WAS REMOVED EASILY FROM THE PATIENT AND WAS INTACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WAS NOT RETUNED FOR ANALYSIS. REVIEW OF LOT 15736739 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 LIMITED INFORMATION AVAILABLE FOR REVIEW, CLINICAL FACTORS (SUCH AS VESSEL CHARACTERISTICS) CONTRIBUTING TO THE BURST ARE UNKNOWN. BALLOON BURST IS A WELL KNOWN PROCEDURAL COMPLICATION DURING ANGIOPLASTY WHERE PROCEDURAL FACTORS AND VESSEL CHARACTERISTICS OFTEN CONTRIBUTE TO THE DAMAGE. IN THIS CASE, NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED BURST COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE 80 CM. POWERFLEXPRO 7 MM. X 4 CM. BALLOON CATHETER (BC) RUPTURED AT SEVEN ATMOSPHERES (7 ATM.) DURING THE INITIAL INFLATION. CONTRAST LEAKAGE WAS NOTED. THE PRODUCT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANOTHER 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 ILIAC ARTERY. THE PERCENT STENOSIS WAS UNKNOWN. NO ADDITIONAL TARGET LESION CHARACTERISTIC INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION PRIOR TO USE. THERE WAS NO INFORMATION PROVIDED REGARDING CONTRAST OR THE CONTRAST TO SALINE RATIO USED. AN UNKNOWN INFLATION DEVICE WAS USED FOR THE PROCEDURE AND WAS USED SUBSEQUENTLY WITH OTHER DEVICES. THERE WAS NO REPORTED DIFFICULTY OR RESISTANCE/FRICTION REPORTED DURING ADVANCEMENT THROUGH THE GUIDING CATHETER OR ACCESSING THE LESION. THERE WAS NO REPORTED DIFFICULTY ACCESSING THE TARGET LESION AND THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE CATHETER DID NOT KINK DURING USE. THE CATHETER WAS REMOVED EASILY FROM THE PATIENT AND WAS INTACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360032 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15736739

    Patients

    Seq Age Sex Outcome Treatment
    1