BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 5228035 · Received November 16, 2015

    Report

    Report Number
    1226348-2015-00078
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 26, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED AT THE ANALYSIS SITE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS 1 OF 2 REPORTS ASSOCIATED WITH REPORT 1226348-2015-00079. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: NEURON 053, A DAC AND SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN), SHUTTLE SHEATH, NEURON 070 AND SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN), 1CC SYRINGE (DETAILS UNKNOWN), ANOTHER SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN), 8X30 FRAME COIL (DETAILS UNKNOWN), 5 SUBSEQUENT COILS (DETAILS UNKNOWN), GALAXY (640CR1030/16114169).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE HOSPITAL CONTACT THAT THE GALAXY (640CR1030/(B)(4)) WAS DIFFICULT TO POSITION AND STRETCHED AND THE GALAXY (640CR1030/(B)(4)) FELT TIGHT DURING ADVANCEMENT AND DETACHED EARLY. DURING COILING OF RUPTURED ANEURYSM, PHYSICIAN ATTEMPTED TO FRAME 1CM ACOM ANEURYSM WITH A 10X30 GALAXY COIL. PATIENT HAD TYPE 2 ARCH AND ACCESS WAS REPORTED TO BE VERY DIFFICULT. CONTINUOUS FLUSH AND IFU COIL PROCEDURES WERE BOTH ADHERED TO DURING THE PROCEDURE. DURING THE FIRST COIL INCIDENT, ACCESS WAS COMPLETED WITH A NEURON 053, A DAC AND SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN). WHEN THE COIL WAS REPOSITIONED AND COMPLETELY OUT OF THE ANEURYSM, PHYSICIAN REPORTED SEEING COIL LOOK LIKE IT HAD STRETCHED. COIL WAS REMOVED FROM THE SL-10 AND SET ASIDE FOR EVALUATION. NO PATIENT INJURY RESULTED. DURING THE SECOND COIL INCIDENT, ACCESS WAS COMPLETED WITH A SHUTTLE SHEATH, NEURON 070 AND SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN). THE PHYSICIAN REPORTED THAT THE COIL FELT TIGHT DURING ADVANCEMENT. WHEN IT WAS MANIPULATED PRIOR TO PLACEMENT, PHYSICIAN REPORTED THAT IT APPEARED TO HAVE DETACHED EARLY. PHYSICIAN REMOVED MICROCATHETER AND FLUSHED IT WITH A 1CC SYRINGE (DETAILS UNKNOWN). THE RT REPORTED SEEING THE COIL ¿SHOOT OUT¿ THE DISTAL TIP BUT THE CIRCULATOR COULD NOT FIND THE COIL. NO PATIENT INJURY RESULTED. THE SL-10 WAS REPLACED FOR ANOTHER SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN). FINALLY, A 8X30 FRAME COIL (DETAILS UNKNOWN) WAS USED TO FRAME THE ANEURYSM. 5 SUBSEQUENT COILS (DETAILS UNKNOWN) WERE USED TO TREAT THE ANEURYSM WITHOUT INCIDENT. PRODUCTS ARE AVAILABLE FOR RETURN. THE FELLOW REPORTED THAT THE SEVERE TORTUOSITY OF THE ARCH AND INTERNAL CAROTID ARTERY WAS INITIAL ACCESS AND FIRST COIL PLACEMENT VERY DIFFICULT. THE PATIENT WAS A (B)(6) Y.O. FEMALE. A NON-STERILE OG TDL CMPLX FRAME COIL 10X30 WAS RECEIVED COILED INSIDE OF A COIL DISPENSER INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND NO DAMAGES WERE NOTED ON IT. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. NO DAMAGES WERE NOTED ON THE SUPPORT COIL AND THE GRIPPER AND THE EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND ELONGATED WHILE THE EMBOLIC COIL WAS FOUND STRETCHED AND THE SUTURE OF IT WAS FOUND BROKEN. THE EDGES OF THE BROKEN SECTION SHOW EVIDENCE THAT APPEAR THAT IT WAS ELONGATED BEFORE IT WAS BROKEN. THE REVIEW OF LOT 17260969 REVEALED NO ISSUES THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE CUSTOMER AS ¿COIL - POSITIONING DIFFICULTY¿ COULD NOT BE EVALUATED. THE FAILURE EXPERIENCED BY THE CUSTOMER APPEARS WAS DUE TO THE STRETCHED CONDITION FOUND ON THE EMBOLIC COIL. THE FAILURE REPORTED BY THE CUSTOMER AS¿ COIL - UNRAVELED/STRETCHED¿ WAS CONFIRMED. THE CAUSE OF THE STRETCHED CONDITION ON THE EMBOLIC COIL WAS APPARENTLY CAUSED BY APPLYING EXCESSIVE FORCE ON THE DEVICE BUT IT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER THIS DEFECT COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THIS DAMAGE. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF FAILURES FROM LEAVING THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COILING OF RUPTURED ANEURYSM, PHYSICIAN ATTEMPTED TO FRAME 1CM ACOM ANEURYSM WITH A 10X30 GALAXY COIL (640CR1030). PATIENT HAD TYPE 2 ARCH AND ACCESS WAS REPORTED TO BE VERY DIFFICULT. CONTINUOUS FLUSH AND IFU COIL PROCEDURES WERE BOTH ADHERED TO DURING THE PROCEDURE. DURING THE FIRST COIL INCIDENT, ACCESS WAS COMPLETED WITH A NEURON 053, A DAC AND SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN). WHEN THE COIL WAS REPOSITIONED AND COMPLETELY OUT OF THE ANEURYSM, PHYSICIAN REPORTED SEEING COIL LOOK LIKE IT HAD STRETCH. COIL WAS REMOVED FROM THE SL-10 AND SET ASIDE FOR EVALUATION. NO PATIENT INJURY RESULTED. DURING THE SECOND COIL INCIDENT, ACCESS WITH COMPLETED WITH A SHUTTLE SHEATH, NEURON 070 AND SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN). THE PHYSICIAN REPORTED THAT THE COIL FELT TIGHT DURING ADVANCEMENT. WHEN IT WAS MANIPULATED PRIOR TO PLACEMENT, PHYSICIAN REPORTED THAT IT APPEARED TO HAVE DETACHED EARLY. PHYSICIAN REMOVED MICROCATHETER AND FLUSHED IT WITH A 1CC SYRINGE (DETAILS UNKNOWN). THE RT REPORTED SEEING THE COIL "SHOOT OUT" THE DISTAL TIP BUT THE CIRCULATOR COULD NOT FIND THE COIL. NO PATIENT INJURY RESULTED. THE SL-10 WAS REPLACED FOR ANOTHER SL-10 STRAIGHT MICROCATHETER (DETAILS UNKNOWN). FINALLY, A 8X30 FRAME COIL (DETAILS UNKNOWN) WAS USED TO FRAME THE ANEURYSM. 5 SUBSEQUENT COILS (DETAILS UNKNOWN) WERE USED TO TREAT THE ANEURYSM WITHOUT INCIDENT. PRODUCTS ARE AVAILABLE FOR RETURN. THE FELLOW REPORTED THAT THE SEVERE TORTUOSITY OF THE ARCH AND INTERNAL CAROTID ARTERY WAS INITIAL ACCESS AND FIRST COIL PLACEMENT VERY DIFFICULT. THE PATIENT WAS A (B)(6) FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754995 ORBIT GALAXY DETACHABLE COIL SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC 17260969

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR