BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS PTA CATHETER W/EMBOLIC CAP

    MDR report key: 3035874 · Received February 28, 2013

    Report

    Report Number
    3009106639-2013-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    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

    UPON REVIEW OF THE COMPLAINT DETAILS, AND THE RESULTS OF THE FAILURE INVESTIGATION, THE FAILURE IS AN ACCORDION DEFECT IDENTIFIED ALONG THE BALLOON CAUSED BY THE PHYSICIAN APPLYING EXCESSIVE FORCE. THE APPLICATION OF EXCESSIVE FORCE IN THE DISTAL DIRECTION LIKELY CAUSED THE CRUSHING/CRUMPLING OF THE INNER TUBE, AND INTERFERENCE BETWEEN THE INNER TUBE AND THE GUIDE WIRE DESCRIBED BY THE PHYSICIAN. CRUSHING/CRUMPLING OF THE INNER TUBE MAY HAVE ALSO CONTRIBUTED TO THE DIFFICULTY TO REMOVE THE DEVICE THROUGH 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

    TREATMENT OF VESSEL USING A 3X100 DEVICE, 5FR PINNACLE INTRODUCER SHEATH AND 0.014" COATED GUIDE WIRE. THE PHYSICIAN PREPARED THE DEVICE PER THE IFU INSERTED INTO PATIENT TO THE LESION. AFTER INVAGINATION AND CAPTURE THE PHYSICIAN WAS UNABLE TO GET THE BALLOON BACK INTO THE SHEATH. HE PUSHED THE BALLOON BACK INTO THE ARTERY AND DID A CORRECTIVE MANEUVER AND TRIED TO WITHDRAW AGAIN. HE WAS ABLE TO GET IT BACK INTO THE SHEATH WITH TREMENDOUS EFFORT AND FINALLY GOT THE UNIT OUT OF THE BODY. WHEN THE BALLOON EXITED THE VALVE OF THE SHEATH IT LOCKED INTO THE WIRE. NO PATIENT ISSUES. NO FURTHER TREATMENT OF PATIENT DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88316 PROTEUS PTA CATHETER W/EMBOLIC CAP CATHETER, ANGIOPLASTY, PERIPHERAL, TRAN LIT ANGIOSLIDE LTD. FD1057-01

    Patients

    Seq Age Sex Outcome Treatment
    1