BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2181775 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05330
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. BECAUSE THERE WAS NO REPORT OF LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE AND THAT THE DAMAGE LIKELY 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. 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 BURST PRESSURE AND BALLOON INTEGRITY. IN THIS CASE, THE LESION SITE WAS DESCRIBED AS HEAVILY CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. IT WAS REPORTED THAT IMAGES REVEALED A DISSECTION WHERE PRE-DILATATION HAD BEEN PERFORMED IN THE POPLITEAL. ALTHOUGH A CONCLUSIVE CAUSE FOR THE DISSECTION COULD NOT BE DETERMINED, DISSECTION IS LISTED IN THE FOX PLUS INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE USE OF THE PRODUCT. IN THIS CASE, IT COULD NOT BE DETERMINED IF THE DISSECTION WAS RELATED TO THE USE OF THE PRODUCT. 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 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. OVERALL, A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE AND DISSECTION COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE HEAVILY CALCIFIED LEFT POPLITEAL ARTERY, A 6 X 8 FOX PLUS BALLOON WAS INFLATED ONE TIME TO 8 ATMOSPHERES. THE DILATATION CATHTETER WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE. PRIOR TO DEPLOYMENT OF THE STENT, AN ATTEMPT WAS MADE TO RE-PREP THE BALLOON FOR POST-DILATATION; HOWEVER, THE BALLOON WOULD NOT HOLD PRESSURE. BALLOON RUPTURE WAS SUSPECTED. IMAGES REVEALED A DISSECTION WHERE PRE-DILATATION HAD BEEN PERFORMED IN THE POPLITEAL. A SHORTER STENT HAD BEEN PLANNED FOR TREATMENT OF THE TARGET LESION; HOWEVER, DUE TO THE DISSECTION, A LONGER ABSOLUTE STENT WAS DEPLOYED FOR SUCCESSFUL TREATMENT OF THE TARGET LESION AND THE DISSECTION. 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 559937

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention