BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2203229 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03291
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 15, 2011
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE SHAFT WAS BUCKLED THROUGHOUT THE ENTIRE LENGTH OF THE CATHETER. THE INNER SHAFT WAS STRETCHED AND PULLED 135CM OUT OF THE HUB. ALL ADHESIVE PORT CAVITIES OF THE HUB WERE FILLED WITH ADHESIVE. MAGNIFIED INSPECTION REVEALED MULTIPLE TEARS LOCATED ON THE PROXIMAL AND DISTAL ENDS OF THE BALLOON. THE INNER SHAFT WAS PUNCTURED ON THE DISTAL END WHERE A BALLOON TEAR WAS LOCATED. THE TOTAL LENGTH OF THE CATHETER MEASURED WAS MEASURED AT 293CM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED AND A PARTIAL BALLOON DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED TIBIAL ARTERY. A 4X60 MM STERLING CATHETER WAS SELECTED. THE BALLOON CATHETER ENTERED THE BODY AND WAS ADVANCED WITHOUT DIFFICULTY. AN INFLATION ATTEMPT WAS MADE, BUT THE BALLOON WAS UNABLE TO INFLATE. THE PHYSICIAN WAS UNABLE TO ADVANCE THE CATHETER FORWARD OR BACKWARD. THE BALLOON WAS FORCEFULLY REMOVED FROM THE BODY, AFTER CUTTING THE GUIDE WIRE. IT WAS THEN REPORTED, THE BALLOON PARTIALLY DETACHED FROM THE CATHETER DUE TO THE FORCE USED DURING THE REMOVAL PROCESS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FAVORABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED AND A PARTIAL BALLOON DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED TIBIAL ARTERY. A 4X60 MM STERLING CATHETER WAS SELECTED. THE BALLOON CATHETER ENTERED THE BODY AND WAS ADVANCED WITHOUT DIFFICULTY. AN INFLATION ATTEMPT WAS MADE, BUT THE BALLOON WAS UNABLE TO INFLATE. THE PHYSICIAN WAS UNABLE TO ADVANCE THE CATHETER FORWARD OR BACKWARD. THE BALLOON WAS FORCEFULLY REMOVED FROM THE BODY, AFTER CUTTING THE GUIDE WIRE. IT WAS THEN REPORTED THE BALLOON PARTIALLY DETACHED FROM THE CATHETER DUE TO THE FORCE USED DURING THE REMOVAL PROCESS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FAVORABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING¿ CATHETER, PERCUTANEOUS DQY H74939032406010

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR