BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

    MDR report key: 5885350 · Received August 18, 2016

    Report

    Report Number
    2954740-2016-00183
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Date of Event
    July 22, 2016
    Report Date
    July 25, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K120686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: KRD/HCG. (B)(4). CONCLUSION: THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COIL PROTRUDING INTO THE PARENT VESSEL AND RESHEATHING DIFFICULTY COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN FOR ANALYSIS OR PROCEDURAL FILMS FOR REVIEW. THE ROOT CAUSE OF THE EVENTS COULD NOT BE DETERMINED; HOWEVER, ANEURYSM CHARACTERISTICS (REQUIRED STENT TO HOLD COILS IN PLACE) MAY HAVE CONTRIBUTED TO THE COIL PROTRUSION. PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE RESHEATHING ISSUE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL OF AN UNRUPTURED, 6MM POSTERIOR COMMUNICATING ARTERY ANEURYSM, A G2 TDL COMPLEX FILL COIL (641CF0615/ P10015) PROTRUDED INTO THE PARENT VESSEL DURING POSITIONING, AND COULD NOT BE RE-SHEATHED. INITIALLY, AFTER PLACING THE SL10 MICROCATHETER INTO THE ANEURYSM, HE DECIDED TO USE THE G2 FILL COIL TO FRAME THE ANEURYSM. AFTER TRYING TO DEPLOY THE COIL, THE PHYSICIAN DECIDED THAT THE ANEURYSM WOULD NEED A STENT SINCE THE STENT COULD NOT BE POSITIONED AND PROTRUDED INTO THE PARENT VESSEL. AT THAT TIME, HE STARTED TO PULL THE COIL BACK TO BE RE-SHEATHED AND USED AGAIN AFTER THE STENT WAS DEPLOYED. DURING RE-SHEATHING, THE ZIPPER GOT STUCK ON THE DELIVERY SHEATH MAKING IT IMPOSSIBLE TO RECAPTURE THE COIL FOR REUSE. THE COIL WAS SET ASIDE AND ACCIDENTALLY DISCARDED. THE COIL AND DELIVERY WIRE DID NOT APPEAR DAMAGED AFTER USE. THE PATIENT SUFFERED NO HARM BY THIS ISSUE, AND THE ANEURYSM WAS SUCCESSFULLY TREATED. THE EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538530 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA P10015

    Patients

    Seq Age Sex Outcome Treatment
    1 SL-10 MICROCATHETER