BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2120664 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04128
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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 WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH NO BLOOD VISIBLE AND CONTRAST IN THE BALLOON. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH BEING AT LEAST PARTIALLY INFLATED. THERE WAS A KINK IN THE SHAFT AT THE DISTAL END OF THE STRAIN RELIEF TUBING POSSIBLY DUE TO HANDLING/PACKAGING THE PRODUCT FOR RETURN TO ABBOTT VASCULAR. THERE WAS A CRACK IN THE SIDEARM OF THE HUB, IN LENGTH OF 1.2 CM. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. A NON-ABBOTT SYRINGE WAS RETURNED WITH NO BLOOD VISIBLE AND 3 CC OF CONTRAST FILLED INSIDE. THERE WAS NO DAMAGE NOTED TO THE RETURNED NON-ABBOTT SYRINGE. IN THIS CASE, DURING FUNCTIONAL TESTING THE LEAK WAS CONFIRMED, DUE TO THE CRACK IN THE SIDEARM. A NEW INDEFLATOR WAS FILLED WITH CONTRAST MEDIUM; DILUTED 1:1 WITH COLORED WATER AND WAS USED IN ATTEMPT TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE; HOWEVER, THE BALLOON WOULD NOT INFLATE, FLUID WAS CONSTANTLY LEAKING OUT FROM THE CRACK IN THE SIDEARM. ALTHOUGH A CONCLUSIVE CAUSE FOR THE CRACK IN THE SIDEARM COULD NOT BE DETERMINED, POTENTIAL FACTORS FOR THIS TYPE OF DAMAGE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, MATERIALS, MOLD DEFICIENCIES OR OVER-TIGHTENING A CONNECTING DEVICE. TO ENSURE THIS TYPE OF DAMAGE IS NOT MANUFACTURING RELATED, ALL BALLOON DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. BASED ON THE LOCATION OF THE CRACK, WHICH APPEARS TO ORIGINATE FROM THE THREADED AREA OF THE SIDEARM, IT MAY BE POSSIBLE THAT A CONNECTING DEVICE WAS OVER TIGHTENED AND/OR CROSS-THREADED DURING TIGHTENING. HOWEVER, THIS COULD NOT BE CONFIRMED. 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. A CONCLUSIVE CAUSE FOR THE DAMAGE 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 IT WAS NOT POSSIBLE TO INFLATE THE BALLOON COMPLETELY IN THE ANTERIOR TIBIAL LESION, AS THE INFLATION ALWAYS STOPPED AT 8 BARS. CONTRAST MEDIA WAS SEEN LEAKING OUT OF THE PROXIMAL END OF THE CATHETER WHERE THE SYRINGE FOR FILLING CONTRAST MEDIA IS CONNECTED. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 689227

    Patients

    Seq Age Sex Outcome Treatment
    1