BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A4E04, PYTHON 9MM-80CM

    MDR report key: 6062408 · Received October 27, 2016

    Report

    Report Number
    2027111-2016-00740
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 23, 2016
    Report Date
    May 10, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXE
    UDI-DI
    00607915113438
    PMA / PMN Number
    K970762
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FOLLOW-UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. BASED ON THE DESCRIPTION OF THE EVENT, THE BALLOON WAS INSPECTED PRIOR TO THE PROCEDURE, WHICH IMPLIES THAT THE PRODUCT WAS LIKELY CONFORMANT BEFORE USE. IT IS LIKELY THAT THE UNIT WAS SUBJECTED TO ADVERSE CONDITIONS WITHIN THE VESSEL. THE INSTRUCTIONS FOR USE (IFU) STATES THAT "BALLOON DEGRADATION AND RUPTURE MAY RESULT FROM EXPOSURE TO ADVERSE ENVIRONMENTAL CONDITIONS, EXCESSIVE HANDLING, OR DEPOSITS WITHIN THE VESSEL." APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY.

    Description of Event or Problem · 1

    THE RUPTURE/PINHOLES EVENTS OCCURRED FREQUENTLY LATELY IN (B)(6). (ON (B)(6) 2016: DURING A PROCEDURE) THROMBECTOMY - "A THROMBECTOMY FOR EXTERNAL ILIAC ARTERY AND COMMON ILIAC ARTERY WAS PERFORMED AND PYTHON CATHETER WAS USED FOR THE SURGERY. THE PYTHON CATHETER WAS RUPTURED AFTER THE CATHETER WAS USED FOR THE PROCEDURE A COUPLE OF TIMES. THEN, ANOTHER PACKAGE PYTHON CATHETER WAS OPENED AND USED FOR SURGERY. HOWEVER, THE SECOND CATHETER WAS RUPTURED ON FIRST-TIME USE. AFTER THAT, THIRD PYTHON CATHETER WAS OPENED AND USED FOR THE THROMBECTOMY FOR PERIPHERAL ARTERY. HOWEVER, THE THIRD CATHETER WAS ALSO RUPTURED ON THE FIRST-TIME USE. A MEDICAL STAFF ELECTED TO USE A FOGARTY CATHETER (EDWARDS LIFESCIENCES LLC) AND PROCEED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM." COMMENTS FROM DISTRIBUTOR: "ALTHOUGH NO COMPLAINT DEVICES WERE RETURNED FROM THE HOSPITAL, WE REPORT THIS CASE. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. " PATIENT STATUS - "NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON OCTOBER 6, 2016 FROM DISTRIBUTOR - ASKED TO CLARIFY WHAT WAS MEANT BY "CATHETER WAS RUPTURED" RUPTURED AND RECEIVED RESPONSE STATING THAT "IT'S LIKELY THAT THE BALLOON DEFLATED. THERE WAS NO DAMAGE TO THE VESSEL. THE PATIENT'S BLOOD VESSEL WAS CALCIFIED. THE BLOOD VESSEL CALCIFICATION IS THOUGHT TO BE A POSSIBLE CAUSE." THERE WAS NO DIFFICULTY INSERTING OR REMOVING THE CATHETER. DISTRIBUTOR HAVE NOT BEEN INFORMED OF ANY UNINTENDED MATERIAL LEFT IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON OCTOBER 12, 2016 FROM DISTRIBUTOR - THE MEDICAL STAFF PERFORMED PRIOR-TO-USE CHECK FOR ALL PYTHON CATHETERS. NO LEAKAGE WAS NOTED ON THE BALLOON AT THE PRIOR-TO-USE CHECK. BALLOON WAS INFLATED WITHIN SPECIFIED RANGE OF IFU. SALINE WAS USED TO INFLATE THE BALLOON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RCVD MAY 8, 2017: "PICTURE IS NOT AVAILABLE FOR THIS COMPLAINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710755 A4E04, PYTHON 9MM-80CM DXE DXE APPLIED MEDICAL RESOURCES A4E04 1255539 00607915113438

    Patients

    Seq Age Sex Outcome Treatment
    1