BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2023398 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01807
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RETURNED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE SECOND FOX PLUS IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS NOTED BLOOD IN THE BALLOON AND NO CONTRAST VISIBLE, CONSISTENT WITH USE OF THE DEVICE IN THE ANATOMY. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH HAVING BEEN INFLATED. WHEN INFLATED WITH A NEW INDEFLATOR, A PINHOLE WAS OBSERVED, CONFIRMING THE REPORTED RUPTURE. NO SCRATCHES WERE OBSERVED AND IT WAS NOT VISUALLY CLEAR IF THE RUPTURE WAS ALONG A CREASE OR FOLD. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVE APPLIED PRESSURE, LESION CALCIFICATION OR TORTUOSITY OR INTERACTION WITH THE ANATOMY AND/OR ACCESSORY DEVICES. DURING USE, INTERACTION WITH ANATOMY AND/OR ACCESSORY DEVICES CAN DAMAGE OR WEAKEN THE BALLOON MATERIAL AND LEAD TO RUPTURE DURING INFLATION. IN MANUFACTURING, ALL BALLOON DILATATION CATHETERS ARE VISUALLY INSPECTED FOR BALLOON DAMAGE, AND INFLATED TO RATED BURST PRESSURE ONLINE. IN THIS CASE, THERE WAS NO REPORT OF ANY LEAK DURING PREPARATION FOR USE OR THE FIRST INFLATION, WHICH MAY SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IN THIS SITUATION, THE HEAVY CALCIFICATION LIKELY DAMAGED THE OUTER SURFACE OF THE BALLOON DURING THE FIRST INFLATION, LEADING TO THE BALLOON RUPTURING AT A LOWER VALUE ON THE SECOND INFLATION. SCANNING ELECTRON MICROSCOPY INDICATED THAT THERE WAS MECHANICAL DAMAGE ON THE OUTER SURFACE OF THE BALLOON LEADING INTO THE PINHOLE, WHICH SUPPORTS THE POTENTIAL CAUSE OF CALCIFIED ANATOMY. THIS INCIDENT WILL BE ATTRIBUTED TO OPERATIONAL CONTEXT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE APPEARS TO BE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREDILATATION IN THE VERY HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY THE FOX PLUS BALLOON ((B)(4)) WAS SUCCESSFULLY INFLATED TO RATED BURST PRESSURE (RBP) OF 15 ATM AT THE FIRST INFLATION. DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 14 ATM. THE DELIVERY CATHETER (DC) AND BALLOON WERE COMPLETELY REMOVED WITHOUT DIFFICULTY AND THE LESION WAS DILATATED USING A NON-ABBOTT BALLOON. DURING PREDILATATION IN THE VERY HEAVILY CALCIFIED ILIAC ARTERY LESION ANOTHER FOX PLUS BALLOON ((B)(4)) RUPTURED DURING THE FIRST INFLATION AT 14 ATM, BELOW RBP. THE DC AND BALLOON WERE COMPLETELY REMOVED WITHOUT DIFFICULTY AND THE LESION WAS TREATED USING A NON-ABBOTT BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 687505

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR