BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 5252119 · Received November 26, 2015

    Report

    Report Number
    3005462046-2015-00030
    Event Type
    Malfunction
    Date Received
    November 26, 2015
    Date of Event
    November 4, 2015
    Report Date
    November 4, 2015
    Manufacturer
    ANGIOSCORE, INC
    Product Code
    LIT
    PMA / PMN Number
    K142983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CODES AND DEVICE CODES WERE NOT INCLUDED IN THE INITIAL MDR.

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE 510(K) NUMBER FROM K122685 TO K142983.

    Additional Manufacturer Narrative · 1

    THE BALLOON WAS UNABLE TO DEFLATE; HOWEVER NO PATIENT INJURY WAS REPORTED. RECURRENCE OF THE MALFUNCTION COULD CAUSE A VESSEL OBSTRUCTION, POSSIBLE LIMB ISCHEMIA OR REQUIRING SURGICAL INTERVENTION. THE ANGIOSCULPT DEVICE WAS RETURNED INTACT TO THE INTRODUCER SHEATH. VISUAL EXAMINATION CONFIRMED THE BALLOON WAS INFLATED. THE TIP AND DISTAL BOND WERE DAMAGED AND THE SCORING ELEMENT RINGS WERE EXPOSED. THE PROXIMAL BOND WAS ALSO DAMAGED AND THE DISTAL SHAFT WAS SEVERELY STRETCHED. THE TRANSITION TUBING WAS NECKED AND DETACHED FROM THE PROXIMAL BOND AND KINKS WERE PRESENT ON THE SHAFT. DURING FUNCTIONAL TESTING, THE DEVICE COULD NOT BE REMOVED FROM THE INTRODUCER SHEATH. THE DEVICE WAS THEN CONNECTED TO AN INDEFLATOR AND PULLED VACUUM BUT THE BALLOON WOULD NOT DEFLATE. AN ATTEMPT TO INFLATE THE BALLOON WAS UNSUCCESSFUL. THE DEVICE WAS CUT AT THE DISTAL END OF THE STRAIN RELIEF TO ALLOW REMOVAL FROM THE INTRODUCER SHEATH. THE DEVICE WAS THEN DISSECTED TO MEASURE THE INNER DIAMETER OF THE SHAFT. MEASUREMENTS OF THE INNER DIAMETER RANGING FROM 0.022¿ TO 0.031¿ SUGGEST THAT THE NECKED REGION PREVENTED THE BALLOON FROM DEFLATING. DUE TO THE BALLOON UNABLE TO DEFLATE, SOME DEGREE OF FORCE WAS APPLIED TO REMOVE THE DEVICE FROM THE PATIENT, RESULTING IN THE DAMAGED OBSERVED DURING LAB INVESTIGATION.

    Description of Event or Problem · 1

    THE ANTERIOR TIBIAL ARTERY WAS DILATED AFTER LASERING THE VESSEL. THE ANGIOSCULPT DEVICE WAS INFLATED TO 8 ATM PER THE IFU BUT WAS UNABLE TO DEFLATE. THERE WAS NOTHING UNUSUAL ABOUT THE ANATOMY, LESION OR EQUIPMENT NOTED. THE ANGIOSCULPT WAS REMOVED BY GENTLY PULLING TO REMOVE THE INFLATED BALLOON, GUIDE WIRE, AND SHEATH ALL TOGETHER. THE PROCEDURE WAS STOPPED AND THE PATIENT HAD GOOD DISTAL PULSES AND NO OBVIOUS SIGNS OF INJURY AT POINT OF LEAVING THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782236 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL LIT ANGIOSCORE, INC 2216-30100 F15080026

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other