BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSFRAME COIL

    MDR report key: 5542856 · Received April 1, 2016

    Report

    Report Number
    1226348-2016-00045
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    March 10, 2016
    Report Date
    March 10, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR ANALYSIS, BUT IT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: CODMAN ENTERPRISE 2 23MM AND PROWLER SELECT PLUS STRAIGHT (DETAILS UNKNOWN); SL 10 (DETAILS UNKNOWN); EV3 SNARE (DETAILS UNKNOWN); 3 STRYKER COILS (DETAILS UNKNOWN); COIL (MFR100730/C40400); CABLE (ECB00018200/C19108).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE HOSPITAL CONTACT THAT A 6 MM MICRUSFRAME COIL (MFR100626/C40390) DETACHED FROM THE COIL INTRODUCER AND HAD TO BE PINNED IN THE PROXIMAL CAROTID WITH A CAROTID STENT. THE 7MM MICRUSFRAME COIL (MFR100730/C40400) WAS DEPLOYED THROUGH AN SL 10 (DETAILS UNKNOWN) INTO THE ANEURYSM AFTER THE ENTERPRISE 2 WAS DEPLOYED. PHYSICIAN DECIDED THE COIL WAS TOO LARGE AND MOVED DOWN TO THE 6 MM MICRUSFRAME COIL (MFR100626/C40390). IT WAS INTRODUCED INTO THE SL 10 AND ADVANCED INTO THE ANEURYSM. AS THE COIL WAS BEING INTRODUCED THE SL 10 MICROCATHETER RETRACTED AND CAME PROXIMAL IN THE ARTERY. THE PHYSICIAN TRIED TO PUSH THE SL 10 BACK OVER THE PARTIALLY DEPLOYED COIL (USING IT AS A GUIDEWIRE) TO RE-ENTER THE ANEURYSM. HE WAS UNSUCCESSFUL WITH THIS MANEUVER, AND THEN TRIED TO RETRACT THE COIL OUT OF THE ANEURYSM BACK INTO THE SL 10. THE COIL LOOPS LEFT IN THE ANEURYSM EMBEDDED UNDER THE STENT STRUTS AND WOULD NOT MOVE AS THEY WERE STUCK IN PLACE AT THIS POINT. AS THE PHYSICIAN ATTEMPTED AGAIN TO PULL BACK ON THE COIL, THE COIL DETACHED FROM THE COIL INTRODUCER. HE WAS UNABLE AT THIS POINT TO MOVE THE COIL EITHER DIRECTION. THE PHYSICIAN THEN ATTEMPTED TO SNARE THE COIL WITH AN EV3 SNARE (DETAILS UNKNOWN). HE MADE MULTIPLE ATTEMPTS TO CAPTURE AND RETRACT THE COIL WITH THE SNARE, OVER THE NEXT HOUR BUT ULTIMATELY HE WAS UNSUCCESSFUL. HE THEN DECIDED TO PIN THE TAIL OF THE COIL IN THE PROXIMAL CAROTID WITH A CAROTID STENT. ONCE THIS WAS COMPLETED, HE RE-ENTERED THE ANEURYSM WITH AN SL 10 AND SUCCESSFULLY DEPLOYED 3 STRYKER COILS (DETAILS UNKNOWN). HE COMPLETED THE CASE WITH FOLLOW UP ANGIOGRAMS AND THE PATIENT AWOKE WITHOUT ISSUE. CODMAN ENTERPRISE 2 23MM AND PROWLER SELECT PLUS STRAIGHT (DETAILS UNKNOWN) WERE ALSO USED. THE COIL INTRODUCER AND THE 2 SL 10 MICROCATHETERS WILL BE RETURNED FOR ANALYSIS. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT IMPAIRMENT OR INJURY. THE PROCEDURE WAS FOR TREATMENT OF A 7 MM X 7 MM ICA ANEURYSM THAT HAD MEDIUM TORTUOSITY. VERY LIMITED INFORMATION WAS RECEIVED. THE SL-10 MICROCATHETER AND THE STENT WERE NOT RETURNED. CONCERNING CLEANLINESS ONLY, THE MICROCOIL SYSTEM WAS RETURNED IN ALMOST PRISTINE CONDITION. THE SYSTEM WAS EITHER NOT USED OR WAS CLEANED/RINSED BEFORE BEING RETURNED WHICH MAY HAVE PRODUCED FURTHER DAMAGE. IT IS ALSO UNKNOWN IF THE DEVICE WAS IMPROPERLY HANDLED FOR RETURNED PACKAGING OR WAS FURTHER MANIPULATED AND/OR INSPECTED POST-PROCEDURALLY. IN ADDITION, ANY TRACE OR OTHER EVIDENCE THAT MAY HAVE BEEN COMPLAINT RELATED MAY HAVE BEEN ALTERED OR REMOVED PRIOR TO BEING RETURNED DUE TO POST-PROCEDURAL HANDLING, CLEANING, AND PACKAGING. IT IS VERIFIED THAT THE COIL WAS NOT RETURNED PER COMPLAINT EVENT. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN SEVERELY DAMAGED. THE LOCKING MECHANISM HAS COMPRESSION AND STRETCHING DAMAGE. IT APPEARS THAT THE V NOTCH AND THE LOCKING MECHANISM DAMAGE ARE NOT COMPLAINT RELATED. THE COIL WAS MECHANICALLY DETACHED. NO MANUFACTURING DEFECTS WERE FOUND. THE COMPLAINT OF THE COILS PREMATURE DETACHMENT IS CONFIRMED. WHILE THE EXACT ROOT CAUSE CANNOT BE DETERMINED, THE MOST LIKELY CONTRIBUTING FACTOR SUPPORTED BY THE EVIDENCE AND THE COMPLAINT DESCRIPTION MAY HAVE BEEN DUE TO THE COIL BECOMING EMBEDDED UNDER THE STENTS STRUTS. WHEN THE ANCHORED COIL WAS BEING RETRACTED IT HAD AN UNINTENDED PREMATURE MECHANICAL DETACHMENT FROM THE DEVICE POSITIONING UNIT (DPU). IT IS UNKNOWN HOW MUCH THE BODY¿S ANATOMY CONTRIBUTED TO THE COMPLAINT EVENT. IN ADDITION WITHOUT THE RETURN OF THE COIL, THE SL-10 MICROCATHETER, AND THE STENT USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. THE COMPLAINT OF THE MICROCATHETER MOVING DURING THE COILS INTRODUCTION INTO THE TARGET SITE CANNOT BE CONFIRMED. WITHOUT FILM EVIDENCE AND THE RETURN OF THE COIL AND MICROCATHETER USED IN THE PROCEDURE, THE ROOT CAUSE OF THE MICROCATHETER MOVING OFF THE TARGET SITE CANNOT BE DETERMINED, HOWEVER THE MOST LIKELY CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO DISTAL INTERFERENCE OF AN UNKNOWN SOURCE WHICH MAY HAVE INCLUDED COILS ALREADY DWELLING INSIDE THE TARGET SITE (IF PREVIOUSLY PLACED, ON ITSELF, OR THE DISTAL TIP OF THE MICROCATHETER. IT IS UNKNOWN HOW MUCH THE BODY¿S ANATOMY CONTRIBUTED TO THE COMPLAINT EVENT. IT WAS STATED THAT THE COIL WAS UTILIZED AS A GUIDE WIRE (WHICH MAY HAVE ALSO CONTRIBUTED TO THE UNINTENDED DETACHMENT OF THE COIL). THE COIL SHOULD NOT NORMALLY BE USED AS A GUIDE WIRE. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿CAUTION: DO NOT ATTEMPT TO USE THE MICROCOIL SYSTEM AS A GUIDEWIRE IF POSITIONING OF THE MICROCATHETER IS LOST DURING MICROCOIL DEPLOYMENT. IN ADDITION, WITHOUT THE RETURN OF THE SL-10 MICROCATHETER, THE COIL, AND THE STENT USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL CONTACT THAT A 6 MM MICRUSFRAME COIL (MFR100626/C40390) DETACHED FROM THE COIL INTRODUCER AND HAD TO BE PINNED IN THE PROXIMAL CAROTID WITH A CAROTID STENT. THE 7MM MICRUSFRAME COIL (MFR100730/C40400) WAS DEPLOYED THROUGH AN SL 10 (DETAILS UNKNOWN) INTO THE ANEURYSM AFTER THE ENTERPRISE 2 WAS DEPLOYED. PHYSICIAN DECIDED THE COIL WAS TOO LARGE AND MOVED DOWN TO THE 6 MM MICRUSFRAME COIL (MFR100626/C40390). IT WAS INTRODUCED INTO THE SL 10 AND ADVANCED INTO THE ANEURYSM. AS THE COIL WAS BEING INTRODUCED THE SL 10 MICROCATHETER RETRACTED AND CAME PROXIMAL IN THE ARTERY. THE PHYSICIAN TRIED TO PUSH THE SL 10 BACK OVER THE PARTIALLY DEPLOYED COIL (USING IT AS A GUIDEWIRE) TO RE-ENTER THE ANEURYSM. HE WAS UNSUCCESSFUL WITH THIS MANEUVER, AND THEN TRIED TO RETRACT THE COIL OUT OF THE ANEURYSM BACK INTO THE SL 10. THE COIL LOOPS LEFT IN THE ANEURYSM EMBEDDED UNDER THE STENT STRUTS AND WOULD NOT MOVE AS THEY WERE STUCK IN PLACE AT THIS POINT. AS THE PHYSICIAN ATTEMPTED AGAIN TO PULL BACK ON THE COIL, THE COIL DETACHED FROM THE COIL INTRODUCER. HE WAS UNABLE AT THIS POINT TO MOVE THE COIL EITHER DIRECTION. THE PHYSICIAN THEN ATTEMPTED TO SNARE THE COIL WITH AN EV3 SNARE (DETAILS UNKNOWN). HE MADE MULTIPLE ATTEMPTS TO CAPTURE AND RETRACT THE COIL WITH THE SNARE, OVER THE NEXT HOUR BUT ULTIMATELY HE WAS UNSUCCESSFUL. HE THEN DECIDED TO PIN THE TAIL OF THE COIL IN THE PROXIMAL CAROTID WITH A CAROTID STENT. ONCE THIS WAS COMPLETED, HE RE-ENTERED THE ANEURYSM WITH AN SL 10 AND SUCCESSFULLY DEPLOYED 3 STRYKER COILS (DETAILS UNKNOWN). HE COMPLETED THE CASE WITH FOLLOW UP ANGIOGRAMS AND THE PATIENT AWOKE WITHOUT ISSUE. CODMAN ENTERPRISE 2 23MM AND PROWLER SELECT PLUS STRAIGHT (DETAILS UNKNOWN) WERE ALSO USED. THE COIL INTRODUCER AND THE 2 SL 10 MICROCATHETERS WILL BE RETURNED FOR ANALYSIS. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT IMPAIRMENT OR INJURY. THE PROCEDURE WAS FOR TREATMENT OF A 7 MM X 7 MM ICA ANEURYSM THAT HAD MEDIUM TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198096 MICRUSFRAME COIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL C40390

    Patients

    Seq Age Sex Outcome Treatment
    1