BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1.5MM X 4CM

    MDR report key: 9269083 · Received November 1, 2019

    Report

    Report Number
    3008114965-2019-01221
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    September 18, 2019
    Report Date
    September 19, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080152
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER CONTACT PHONE: (B)(6). MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER CONTACT PHONE: (B)(6). MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2019-01222. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AT THE SUPERIOR RECTAL ART ARTERY FOR HEMORRHAGE, A 4FR TERUMO, SHEPHERD HOOK WAS CANNULATED TO THE IMA AND SL10 MICROCATHETER (MC) WAS APPROACHED TO THE TARGET LESION. TWO 1.5MM X 4CM GALAXY G3 MINI COILS (GLM915040, L14811) WERE USED, BUT THEY DID NOT COME OUT FROM THE GREEN PART OF THE INTRODUCER SHEATH. THEY DID NOT ADVANCE DUE TO SNAKING WITHIN THE SHEATH. THEREFORE, THE COMPLAINT COILS WERE REPLACED WITH ANOTHER COIL. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO SIGNIFICANT PROCEDURAL DELAYS DUE TO THE EVENT. PRIOR TO THE COMPLAINT COILS A 2MMX6MM GALAXY MINI COIL WAS IMPLANTED AND A 1MMX .5X4MM GALAXY MINI COIL WAS IMPLANTED. THE LOT NUMBER OF THE IMPLANTED 1MMX .5X4MM GALAXY MINI WAS DIFFERENT FROM THE COMPLAINT COILS. BASED ON THE VISUAL INSPECTION OF THE PICTURES RECEIVED ON BOTH DEVICES, THERE IS DAMAGE OF EMBOLIC COILS, FOLDED AND KINKED. ONE NON-STERILE UNIT GALAXY G3 MINI 1.5MM X 4CM WAS RECEIVED ON A POUCH. THE HUB WAS INSPECTED, AND NO DAMAGES WAS NOTED ON IT. THE DPU WAS INSPECTED AND IT WAS FOUND SEVERAL KINKED. THE INTRODUCER WAS INSPECTED, AND IT WAS FOUND PARTIALLY ZIPPED AND KINKED. THE RE-SHEATHING TOOL WAS INSPECTED, AND IT WAS FOUND IN GOOD CONDITIONS. THE V-NOTCH WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE NOTED ON IT. THE RH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND IN GOOD CONDITIONS. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND STRETCHED. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE CONDITIONS OF THE RECEIVED DEVICE (DPU-SEVERAL KINKED, INTRODUCER-KINKED, EMBOLIC COIL-STRETCHED). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L14811 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE COMPLAINT REPORTED BY THE CUSTOMER ¿DETACHABLE COIL DELIVERY SYSTEM (DCS) - IMPEDED IN INTRODUCER¿ WAS CONFIRM DUE THE EMBOLIC COIL WAS NOT ABLE TO MOVE THROUGH THE INTRODUCER. HOWEVER, THE STRETCHED CONDITION NOTED ON THE EMBOLIC COIL MAY CONTRIBUTE TO THE FAILURE HOWEVER NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. THE STRETCHED CONDITION APPEARS TO HAVE BEEN CAUSED BY EXCESSIVE FORCE AND HANDLING BEING APPLIED TO THE DEVICE HOWEVER NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE MRE SUGGEST THAT THE FAILURE REPORTED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENTS REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION PROVIDED. HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE AND VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICES; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE AND VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES. IMPEDED IN INTRODUCER IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AT THE SUPERIOR RECTAL ART ARTERY FOR HEMORRHAGE, A 4FR TERUMO, SHEPHERD HOOK WAS CANNULATED TO THE IMA AND SL10 MICROCATHETER (MC) WAS APPROACHED TO THE TARGET LESION. TWO 1.5MM X 4CM GALAXY G3 MINI COILS (GLM915040, L14811) WERE USED, BUT THEY DID NOT COME OUT FROM THE GREEN PART OF THE INTRODUCER SHEATH. THEY DID NOT ADVANCE DUE TO SNAKING WITHIN THE SHEATH. THEREFORE, THE COMPLAINT COILS WERE REPLACED WITH ANOTHER COIL. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO SIGNIFICANT PROCEDURAL DELAYS DUE TO THE EVENT. PRIOR TO THE COMPLAINT COILS A 2MMX6MM GALAXY MINI COIL WAS IMPLANTED AND A 1MMX .5X4MM GALAXY MINI COIL WAS IMPLANTED. THE LOT NUMBER OF THE IMPLANTED 1MMX .5X4MM GALAXY MINI WAS DIFFERENT FROM THE COMPLAINT COILS. BASED ON THE VISUAL INSPECTION OF THE PICTURES RECEIVED ON BOTH DEVICES, THERE IS DAMAGE OF EMBOLIC COILS, FOLDED AND KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062173 GALAXY G3 MINI 1.5MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL L14811 10886704080152

    Patients

    Seq Age Sex Outcome Treatment
    1