BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA PTA CATHETER W/ EMBOLIC CAP

    MDR report key: 2267892 · Received September 6, 2011

    Report

    Report Number
    3008350672-2011-00009
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ANGIOSLIDE LTD.
    Product Code
    LIT
    PMA / PMN Number
    K090364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENTIRE SUBASSEMBLY INCLUDING SHEATH, GUIDE WIRE AND DEVICE WERE REMOVED TOGETHER, ALSO, THE EMBOLIC CAPTURE WAS ALREADY PERFORMED. AS SUCH, THE PROCEDURE WAS COMPLETE AND NO ADD'L INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE DEVICE MALFUNCTION. THE FAILURE IS AN ACCORDION DEFECT IDENTIFIED ALONG THE BALLOON. THIS TYPE OF FAILURE IS LIKELY CAUSED UTILIZATION OF AN INAPPROPRIATELY SIZED GUIDE WIRE AND EXCESSIVE FORCE BEING APPLIED BY THE PHYSICIAN DURING REMOVAL INTO THE INTRODUCER SHEATH. THIS CRUMPLED (ACCORDION LIKE APPEARANCE) OF THE BALLOON POTENTIALLY CAUSES AN INCREASE IN THE CROSSING PROFILE OF THE DEVICE, RESULTING IN INCREASED RESISTANCE AND DIFFICULTY IN WITHDRAWING THE DEVICE THROUGH THE INTRODUCER SHEATH.

    Description of Event or Problem · 1

    TOTAL TREATMENT INVOLVED ANGIOPLASTY AFTER PERFORMING 'OTHER' PROCEDURES. THE ANGIOPLASTY TREATMENT OF LESION INCLUDED USE OF A 7FR SHEATH, 0.014" GUIDE WIRE AND 5 X 100 ANGIOSLIDE DEVICE. DEVICE PREPPED, INSERTED AND INFLATED. PRESSURE REDUCED TO 2 ATM AND EMBOLIC CAPTURE PERFORMED. THE PHYSICIAN WAS INSTRUCTED TO DRAW PULL ROD BACK UNTIL CLICK OCCURS, WHICH HE CONFIRMED. HOWEVER, UPON FURTHER REDUCTION IN PRESSURE, THE REP NOTED IT WAS NOT PULLED ALL THE WAY BACK AND INSTRUCTED PHYSICIAN TO COMPLETE THIS STEP. DEVICE THEN DRAWN BACK INTO SHEATH, BUT RESISTANCE WAS ENCOUNTERED. CORRECTIVE MANEUVERS PERFORMED, BUT WITHDRAW OF DEVICE THROUGH SHEATH WAS UNSUCCESSFUL SO, THE PHYSICIAN REMOVED THE SHEATH, GUIDE WIRE AND DEVICE ALL AS ONE UNIT. THIS FINISHED THE VESSEL TREATMENT, NO FURTHER TREATMENT PERFORMED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRA PTA CATHETER W/ EMBOLIC CAP CATHETER, ANGIOPLASTY, PERIPHERAL, TRAN LIT ANGIOSLIDE LTD. FD1007-01

    Patients

    Seq Age Sex Outcome Treatment
    1