BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 3911151 · Received July 2, 2014

    Report

    Report Number
    2024168-2014-04341
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 11, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K111899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE CATH: 6.0 F, 7.0 F. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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 REPORTED BALLOON RUPTURE AND DIFFICULT TO REMOVE WAS CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION AND SCANNING ELECTRON MICROSCOPY OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NON-CONFORMING MATERIAL REPORTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR BALLOON RUPTURE AND DIFFICULT TO REMOVE INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, DE NOVO MID FEMORAL ARTERY LESION. REPORTEDLY, AFTER ADVANCING THROUGH THE GUIDING CATHETER, THE ARMADA 35 BALLOON WAS INFLATED DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS; HOWEVER, THE BALLOON BURST IN A CIRCUMFERENTIAL DIRECTION. AFTER THE BALLOON BURST, STRONG RESISTANCE WAS FELT DURING REMOVAL OF THE BALLOON. A LITTLE MORE PULL WAS USED AND THE BALLOON AND GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT. A NEW GUIDING CATHETER AND ARMADA 35 WERE USED AND PLACED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385988 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 30830G1

    Patients

    Seq Age Sex Outcome Treatment
    1