BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2193116 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05547
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RETURNED ARMADA BALLOON HAD BLOOD AND CONTRAST IN THE BALLOON, CONSISTENT WITH A LEAK WHILE IN THE ANATOMY. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH BEING INFLATED. THERE WAS A HOLE IN THE INNER MEMBER AND IN THE BALLOON WHERE THE SEPARATED PORTION OF THE GUIDE WIRE WAS PROTRUDING. AFTER THE SEPARATED PORTION OF THE GUIDE WIRE WAS REMOVED FROM THE BALLOON, THERE WERE TWO KINKS NOTED IN THE TIP 3 MM AND 1 CM PROXIMAL TO THE TIPBALL. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE INNER DIAMETER OF THE BALLOON CATHETER WAS NOT MEASURED DUE TO THE DAMAGE NOTED TO INNER MEMBER. POTENTIAL FACTORS WHICH COULD RELATE TO TORN MATERIAL INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, INTERACTION WITH CALCIFIED ANATOMY AND/OR INTERACTION WITH ASSOCIATED DEVICES. IN THIS CASE, THE ARMADA WAS RETURNED WITH THE PROXIMAL PORTION OF THE SEPARATED WHISPER GUIDE WIRE PROTRUDING THROUGH THE INNER MEMBER AND BALLOON MATERIAL CAUSING THE TEAR. THERE WAS NO REPORTED ISSUE WITH THE ARMADA 14 BALLOON CATHETER. ALTHOUGH THE ANALYSIS NOTED THAT THE PROXIMAL END OF THE SEPARATED WHISPER GUIDE WIRE HAD PUNCTURED THROUGH THE INNER MEMBER AND BALLOON MATERIAL OF THE ARMADA, THIS APPEARS TO BE A SECONDARY EFFECT OF THE WHISPER GUIDE WIRE SEPARATION AND DIFFICULTY WITH THE INTRODUCER SHEATH AS ORIGINALLY REPORTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) FOR THIS LOT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED. BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE WHISPER GUIDE WIRE IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE NARROW, MILDLY CALCIFIED, POSTERIOR TIBIAL ARTERY, DURING REMOVAL OF THE WHISPER GUIDE WIRE THROUGH THE NON-ABBOTT INTRODUCER SHEATH RESISTANCE WAS MET AND IT WAS SUSPECTED THAT THE WIRE SEPARATED, BUT IT WAS SUCCESSFULLY REMOVED. NO FRAGMENT OF THE DEVICE WAS LEFT IN THE VESSEL. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THE PROCEDURE ENDED WITH GOOD FLOW TO THE VESSEL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. RETURN DEVICE ANALYSIS NOTED THE SEPARATED PORTION OF THE GUIDE WIRE WAS LOCATED IN THE INNER MEMBER SHAFT INSIDE THE BALLOON AND WAS PROTRUDING THROUGH THE INNER MEMBER SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 695629

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: BIOTRONIK