BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2132885 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04326
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH NO BLOOD VISIBLE AND CONTRAST IN THE BALLOON AND INFLATION LUMEN AND ON THE SHAFT. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH BEING INFLATED. ALTHOUGH NOT REPORTED, THERE WERE MULTIPLE KINKS THROUGHOUT THE ENTIRE LENGTH OF THE SHAFT. THESE KINKS ARE LIKELY THE RESULT OF HANDLING/PACKAGING THE FOX PLUS FOR RETURN TO ABBOTT VASCULAR. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON CATHETER WAS RETURNED INSERTED IN A NON-ABBOTT 6 F INTRODUCER SHEATH. THE NON-ABBOTT INTRODUCER SHEATH WAS RETURNED WITH BLOOD AND CONTRAST ON THE SHAFT. THERE WERE TWO KINKS IN THE SHAFT 1.3 CM AND NON-ABBOTT INTRODUCER SHEATH. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE DISTAL END OF THE NON-ABBOTT INTRODUCER SHEATH. A .087 INCH PIN GAUGE WAS USED. DURING FUNCTIONAL TESTING, A NEW INDEFLATOR FILLED WITH WATER WAS USED TO INFLATE THE BALLOON TO RATED BURST PRESSURE (RBP). THE BALLOON INFLATED TO RBP WITH NO ANOMALIES NOTED. NEGATIVE PRESSURE WAS PULLED AND THE BALLOON DEFLATED IN A TRI FOLD. THE RETURNED BALLOON CATHETER WAS REMOVED FROM THE NON-ABBOTT INTRODUCER SHEATH WITH RESISTANCE NOTED. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT WITHIN THE OMNILINK ELITE STENT, AND REQUIRED FORCE TO PLACE THE BALLOON. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE WARNS: DO NOT ADVANCE THE FOX PLUS AGAINST SIGNIFICANT RESISTANCE. THE CAUSE OF RESISTANCE SHOULD BE DETERMINED VIA FLUOROSCOPY AND REMEDIAL ACTION TAKEN. IN THIS CASE, IT COULD NOT BE DETERMINED IF THE ADVANCEMENT WITH FORCE AGAINST RESISTANCE CAUSED OR CONTRIBUTED TO THE DIFFICULTY REMOVING THE SYSTEM THROUGH THE INTRODUCER SHEATH. POSSIBLE CAUSES FOR DIFFICULTY REMOVING A DILATATION CATHETER AFTER INFLATION MAY INCLUDE: INTERACTION OF THE BALLOON WITH ASSOCIATED DEVICES, THE BALLOON NOT BEING FULLY DEFLATED, DAMAGE TO THE BALLOON, BALLOON REFOLD, KINKS, BENDS, OBSTRUCTIONS IN THE SHEATH, OR DAMAGE TO THE SHEATH. TO HELP ENSURE THIS DIFFICULTY IS NOT RELATED TO A MANUFACTURING DEFICIENCY, THE PROFILE DIMENSIONS ON ALL BALLOON CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE. IN THIS CASE, BASED ON THE REPORTED INFORMATION AND RETURNED DEVICE ANALYSIS, IT MAY BE POSSIBLE THAT THE KINKS NOTED IN THE NON-ABBOTT INTRODUCER SHEATH CONTRIBUTED TO THE RESISTANCE. BALLOON REFOLD MAY ALSO BE A CONTRIBUTING FACTOR. IMPROPER BALLOON REFOLD MAY BE RELATED TO, BUT NOT LIMITED TO, INTERACTION WITH ASSOCIATED DEVICES, BALLOON NOT BEING FULLY DEFLATED OR MULTIPLE INFLATIONS DONE DURING THE PROCEDURE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED RESISTANCE AND DIFFICULTY REMOVING COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR DAMAGE ON THE MANUFACTURING LINE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. SHEATH 6 FR; STENT: UNK OMNILINK ELITE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. AN UNK OMNILINK ELITE IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON A HEAVILY CALCIFIED ILIAC ARTERY (KISSING ILIAC PRIMITIVE), TO TREAT A HEAVILY CALCIFIED LESION. AN OMNILINK ELITE STENT WAS IMPLANTED IN THE RIGHT ILIAC ARTERY AND ANOTHER OMNILINK ELITE STENT WAS IMPLANTED IN THE LEFT ILIAC ARTERY. THE DELIVERY SYSTEM BALLOONS OF BOTH STENTS WERE DEFLATED AND REMOVED FROM THE PATIENT WITHOUT ISSUE. POST-DILATATION WAS PERFORMED IN THE RIGHT ILIAC ARTERY WITH A FOX PLUS 9 X 20 MM BALLOON. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT IN THE OMNILINK ELITE, AND REQUIRED FORCE TO PLACE THE BALLOON. THE BALLOON WAS INFLATED AT 10 BARS AND WAS DEFLATED. DURING REMOVAL, THE FOX PLUS BALLOON ENCOUNTERED RESISTANCE AND COULD NOT BE WITHDRAWN INTO THE 6 FRENCH INTRODUCER SHEATH. THE BALLOON WAS REMOVED FROM THE ANATOMY AS A UNIT WITH THE INTRODUCER SHEATH. AFTER REMOVAL, THE FOX PLUS BALLOON WAS NOTED TO APPEAR IRREGULAR, AS THE DISTAL PART APPEARED LARGER THAN NORMAL. A NEW 6 FRENCH INTRODUCER SHEATH WAS INSERTED AND A CONTROL CHECK OF THE IMPLANTED STENTS WAS PERFORMED. IT WAS OBSERVED THAT THE OMNILINK ELITE WHICH WAS IMPLANTED IN THE RIGHT ILIAC ARTERY APPEARED DEFORMED. THE PHYSICIAN DECIDED TO IMPLANT TWO ADDITIONAL OMNILINK ELITE STENTS INSIDE THIS STENT TO RESHAPE IT. THE FINAL CONTROL CHECK WAS GOOD. THE PATIENT CONDITION AFTER THE PROCEDURE IS GOOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 681693

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR