BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2240252 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06221
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED ARMADA DILATATION CATHETER NOTED BLOOD IN THE GUIDE WIRE LUMEN, WHICH IS CONSISTENT WITH IT BEING ADVANCED OVER A GUIDE WIRE. THE DISTAL END OF THE BALLOON WAS BUNCHED AND THE MIDDLE PORTION OF THE BALLOON WAS WRINKLED, CONSISTENT WITH THE REPORTED DIFFICULTY BEING REMOVED WHEN PULLING THROUGH THE SHEATH. THE INTRODUCER SHEATH USED DURING THE PROCEDURE WAS NOT RETURNED. DURING FUNCTIONAL TESTING, AN INDEFLATOR, FILLED WITH GRASTROGRAFIN DILUTED 1:1 WITH WATER, WAS USED TO INFLATE THE BALLOON BUT FLUID WAS OBSERVED LEAKING THROUGH THE DISTAL END OF THE STRAIN RELIEF TUBING. THE SHAFT WAS LOOSE INSIDE THE STRAIN RELIEF TUBING BUT WAS NOT SEPARATED. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. ALTHOUGH A CONCLUSIVE CAUSE FOR THE BALLOON REFOLDING FLAT COULD NOT BE DETERMINED, POTENTIAL FACTORS INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION WITH ASSOCIATED DEVICES, BALLOON NOT BEING FULLY DEFLATED, MULTIPLE INFLATIONS DURING THE PROCEDURE AND/OR HIGH PRESSURE INFLATIONS. IN THIS CASE, IT WAS REPORTED THAT THE BALLOON WAS INFLATED A SECOND TIME WHEN IT WAS OBSERVED TO REFOLD FLAT. IT IS POSSIBLE THAT THE BALLOON WAS INFLATED TO A HIGH PRESSURE THE FIRST TIME CAUSING FATIGUE TO THE BALLOON MATERIAL RESULTING IN AN IMPROPER REFOLD AFTER THE SECOND INFLATION. HOWEVER, THIS COULD NOT BE CONFIRMED. THE LEAK NOTED AT THE DISTAL END OF THE STRAIN RELIEF TUBING AND LOOSE SHAFT MAY BE THE RESULT OF PULLING THE CATHETER WITH FORCE DURING THE REPORTED DIFFICULTY REMOVING THE CATHETER THROUGH THE SHEATH. A REVIEW OF THE DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT RELEVANT TO THIS REPORT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE BALLOON REFOLDING FLAT COULD NOT BE DETERMINED, THERE IS NO INDICATION TO SUGGEST 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE ARMADA 14 BALLOON WAS INFLATED A SECOND TIME AND IT DEFLATED FLAT, WHICH RESULTED IN DIFFICULTY PULLING IT INTO THE SHEATH. THE BALLOON CATHETER WAS REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE PROCEDURE WAS COMPLETED WHEN THE BALLOON WAS REMOVED. 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 707747

    Patients

    Seq Age Sex Outcome Treatment
    1