BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3250786 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04720
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SHAFT SEPARATION WAS ABLE TO BE CONFIRMED. THE RESISTANCE WITH THE GUIDE WIRE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON A VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID ANTERIOR TIBIAL ARTERY. DIFFICULTY WAS ENCOUNTERED IN RETRACTING A COMMAND GUIDE WIRE FROM THE ARMADA 14 BALLOON. UPON TRYING TO PULL THE GUIDE WIRE FROM THE ARMADA BALLOON, THE PROXIMAL PART OF THE HUB OF THE BALLOON CATHETER BECAME SEPARATED FROM THE SHAFT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ISSUE WITH THE COMMAND GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352798 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 797851

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: COMMAND 300CM