BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP

    MDR report key: 3057088 · Received April 15, 2013

    Report

    Report Number
    3004066202-2013-00051
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 27, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PATIENT CONDITION AFFECTED EFFECTIVENESS OF THE DEVICE (PATIENT LESION MORPHOLOGY, 99% STENOSIS AND MODERATELY CALCIFIED LESION); RELATED TO OPERATIONAL CONTEXT (THE DAMAGED NOTED ON THE RETURNED DEVICE COULD BE ATTRIBUTED TO ROBUST HANDLING DURING THE PROCEDURE). (B)(4).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE AN AMPHIPRION DEEP PTA BALLOON CATHETER ALONG WITH A SKIPPER DEEP PERIPHERAL GUIDE-WIRE TO TREAT A LESION IN THE PERONEAL ARTERY (A FIBULARIS). THE LESION WAS REPORTED TO BE DIFFUSE WITH 99% STENOSIS AND MODERATE CALCIFICATION. THE BALLOON AND GUIDE-WIRE WERE FLUSHED AND INSPECTED BEFORE USE AND NO ABNORMALITIES WERE NOTED. NO RESISTANCE WAS NOTED DURING THE BALLOON INSERTION IN THE GUIDE CATHETER OR THE INTRODUCER SHEATH, HOWEVER FRICTION WAS REPORTED WITH THE GUIDE WIRE AND IT WAS REPORTED THAT THE SKIPPER DEEP GUIDE-WIRE WAS INCOMPATIBLE WITH THE AMPHIPRION DEEP DEVICE. THE DISTAL SHAFT AND THE TIP KINKED DURING THE PROCEDURE AND IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. THE BALLOON WAS ALSO UNABLE TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATION: THE CATHETER WAS RETURNED TO THE MANUFACTURING FACILITY. A SPECIFIC AND EXTENSIVE VISUAL INSPECTION OF THE ENTIRE CATHETER WAS PERFORMED UNDER THE MAGNIFYING GLASS. AFTER AN ACCURATE EXAMINATION, A SMALL DEFECT ON THE GUIDE-WIRE TUBE UNDER THE PROXIMAL PART OF THE BALLOON WAS DETECTED. A CUT ALONG THE WORKING LENGTH OF THE CATHETER SHAFT WAS DETECTED. VISUAL EXAMINATION OF THE GUIDE-WIRE IDENTIFIED THAT THE GUIDE-WIRE TUBE WAS DAMAGED AND RIDGED AND THERE WAS A CUT VISIBLE ON THE CATHETER SHAFT. THE DEVICE SHOWED EVIDENCE OF BEING USED AS THE BALLOON RETURNED UNFOLDED. A FLUSHING OF THE GUIDE WIRE LUMEN WAS PERFORMED BY CONNECTING A SYRINGE FILLED BY WATER TO THE HUB, AND NO LEAKS WERE IDENTIFIED. A 0.014 GUIDE-WIRE WAS INSERTED IN THE HUB OF THE CATHETER AND NO FRICTION WAS DETECTED. DURING THE INFLATION TEST OF THE BALLOON, A LEAKAGE WAS DETECTED WHERE THE SHAFT WAS CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161684 AMPHIRION DEEP CATHETER, PERCUTANEOUS DQY INVATEC SPA 1C020951

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR