BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3103382 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02920
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. ALTHOUGH THE MISLABELING WAS ABLE TO BE CONFIRMED, REVIEW OF THE NOTED INFORMATION SUGGESTS THAT A POTENTIAL MIX-UP MAY HAVE OCCURRED AT THE HOSPITAL. 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 CHIPBOARD BOX WAS SEALED PRIOR TO THE DEVICE BEING REMOVED FROM THE CHIPBOARD BOX. THE CHIPBOARD BOX WAS LABELED AS A 2.5X200 MM ARMADA BALLOON CATHETER WITH LOT NUMBER 804282. THE PACKAGING AND DEVICE INSIDE THE CHIPBOARD BOX PACKAGING WAS LABELED AS A 2.5X120 MM ARMADA BALLOON CATHETER WITH LOT NUMBER 722700; HOWEVER, THIS WAS NOT NOTED UNTIL AFTER THE BALLOON HAD BEEN ADVANCED TO THE LESION AND INFLATED. ON ANGIOGRAPHY THE BALLOON LOOKED SHORT. THE BALLOON CATHETER WAS RETRACTED FROM THE PATIENT, AND UPON INVESTIGATION THE SIZE ON THE HUB OF THE DEVICE WAS A 2.5X120 MM. A NEW ARMADA 14 DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204214 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 804282

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR