BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 3882283 · Received June 18, 2014

    Report

    Report Number
    2024168-2014-03922
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K111899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: TERUMO GLIDEWIRE; INFLATION DEVICE: CONQUEST; SHEATH: 6 FRENCH COOK SHEATH. INFLATION ABOVE RBP (RATED BURST PRESSURE). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE RBP FOR THIS DEVICE AS LABELED ON THE PACKAGING IS 15 ATMOSPHERES. IT SHOULD BE NOTED THAT THE ARMADA 35 INSTRUCTION FOR USE WARNS: INFLATION IN EXCESS OF THE RBP MAY CAUSE THE BALLOON TO RUPTURE. DISSECTION AND PAIN ARE LISTED THE ARMADA 35 INSTRUCTION FOR USE AS POTENTIAL COMPLICATIONS, WHICH MAY OCCUR AS A RESULT OF PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARMADA WAS ADVANCED WITHOUT RESISTANCE TO THE HEAVILY CALCIFIED, UPPER EXTREMITY ARTERIOVENOUS FISTULA THROUGH THE BRACHIAL ACCESS SITE. THE ARMADA WAS TAKEN PAST THE RATED BURST PRESSURE (RBP) TO TREAT THE LESION AND THE ARMADA RUPTURED WITH THE FIRST INFLATION. RESISTANCE WAS FELT BETWEEN THE ARMADA AND THE 6 FRENCH SHEATH DURING RETRACTION. A PIECE OF THE BALLOON SEPARATED, BUT WAS SUCCESSFULLY ASPIRATED OUT OF THE LESION USING THE END OF THE SHEATH. A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF NUMBNESS AND PAIN IN THE HAND. THE HAND WAS ALSO NOTED TO BE DISCOLORED. THE PATIENT WAS TAKEN TO SURGERY TO TREAT AN INTIMAL DISSECTION IN THE TARGET LESION. THE DISSECTION HAD OCCLUDED THE PATIENT'S BLOOD FLOW RESULTING IN THE PATIENT SIGNS AND SYMPTOMS. THE SURGICAL NOTE INDICATED THAT THERE WAS NO REMNANT OF THE BALLOON SEEN IN THE ANATOMY. IT WAS UNKNOWN WHICH DILATATION CATHETER CAUSED THE DISSECTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358163 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 40116G1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES