BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS PTA CATHETER W/ EMBOLIC CAP

    MDR report key: 4853076 · Received June 11, 2015

    Report

    Report Number
    3009106639-2015-00001
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 13, 2015
    Report Date
    June 11, 2015
    Manufacturer
    ANGIOSLIDE LTD.
    Product Code
    LIT
    PMA / PMN Number
    K090364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE CAREFULLY REVIEWED WITH SPECIAL ATTENTION TO RAW MATERIALS, SUBASSEMBLIES AND MFG PROCESS AND QUAL CONTROL TESTING. THIS LOT MEET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. DURING THE VISUAL INSPECTION WE NOTICED THAT THE OUTER TUBE DETACHED FROM THE HANDLE. THIS SEEMS TO BE CAUSED BY APPLYING EXCESSIVE FORCE DURING THE PROCEDURE. PLEASE NOTE, IN THE IFU IT IS CLEARLY STATED UNDER WARNINGS SECTION THAT "THE APPLICATION OF EXCESSIVE PROXIMAL FORCE WHEN RETRACTING THE DEVICE INTO THE SHEATH MAY DAMAGE THE BALLOON AND RESULT IN DIFFICULTY IN RETRIEVING THE CATHETER".

    Description of Event or Problem · 1

    TREATMENT OF LEFT SFA WITH 5X100 BALLOON ACCESSED WITH 0.035" GUIDE WIRE AND 7FR SHEATH. DEVICE PREPARED PER IFU AND INSERTED INTO PT. INFLATED TO 8 ATM FOR 1 MINUTE THEN TAKEN DOWN TO 2 ATM AND CAPTURE PROCESS INITIATED. AFTER INVAGINATION AND CAPTURE THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE BUT IT WAS TUCK INSIDE THE SHEATH. THE DEVICE WAS ADVANCED FORWARD INTO THE PT BODY, RE-INFLATED TO 3 ATM AND THE HANDLE WAS ADVANCED TO UNFOLD THE BALLOON, WHICH WAS CONFIRMED BY FLUOROSCOPY. UPON A SECOND DEFLATION, THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON. THE PHYSICIAN INDICATED THAT THE OUTER TUBE DETACHED FROM THE HANDLE. GUIDED BY FLUOROSCOPY, THE PHYSICIAN PUNCHED AND DEFLATED THE BALLOON, AND SUCCESSFULLY REMOVED THE DEVICE THROUGH THE SHEATH. POST ANGIOGRAPHY REVEALED INTACT VESSEL WITH NO DISSECTION OR ANY DAMAGED INFLICTED TO THE PT ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383711 PROTEUS PTA CATHETER W/ EMBOLIC CAP CATHETER, ANGIOPLASTY, PERIPHERAL, LIT ANGIOSLIDE LTD. FD1077-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention