BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2170560 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05056
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED BALLOON CATHETER FOUND BLOOD IN THE BALLOON AND HUB AND NO CONTRAST VISIBLE. BLOOD IN THE BALLOON IS CONSISTENT WITH A LEAK IN THE ANATOMY. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH BEING INFLATED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. DURING FUNCTIONAL TESTING, THE REPORTED BALLOON RUPTURE WAS CONFIRMED. A NEW INDEFLATOR FILLED WITH WATER WAS USED IN ATTEMPT TO INFLATE THE BALLOON TO RATED BURST PRESSURE (RBP), WHEN IT WAS OBSERVED THAT FLUID WAS COMING OUT FROM A PINHOLE IN THE BALLOON 2 MM DISTAL TO THE PROXIMAL BALLOON MARKER. THERE WAS A SCRATCH IN THE BALLOON AT THE PROXIMAL BALLOON MARKER IN LENGTH OF 1MM, SUGGESTING MECHANICAL DAMAGE TO THE OUTER SURFACE. THERE WAS NO REPORT OF LEAKS NOTED DURING PREPARATION FOR USE; SUGGESTING THAT THE BALLOON DAMAGE OCCURRED DURING USE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE DURING THE PROCEDURE, THIS CAN CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE BALLOON. IN THIS CASE THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS OF A NON-ABBOTT STENT IN THE INTERNAL ILIAC ARTERY, WITH HEAVY CALCIFICATION. THIS SUGGESTS THAT THE BALLOON RUPTURE IS LIKELY DUE TO INTERACTION WITH THE STENT AND/OR HEAVY CALCIFICATION. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED RBP AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS FOR DIFFICULT TO POSITION REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THE BALLOON RUPTURE APPEARS TO BE RELATED TO MECHANICAL DAMAGE TO THE OUTER SURFACE OF THE MATERIAL. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS OF A NON-ABBOTT STENT IN THE INTERNAL ILIAC ARTERY, WITH HEAVY CALCIFICATION. THE FOX BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 10 ATMOSPHERES. AFTER REMOVAL, IT WAS NOTED THAT THERE WAS BLOOD IN THE BALLOON, AND A BALLOON RUPTURE HAD OCCURRED. A NEW FOX BALLOON WAS USED TO COMPLETE THE PROCEDURE WITH A GOOD RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 626509

    Patients

    Seq Age Sex Outcome Treatment
    1