BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2.5MM X 4.5CM

    MDR report key: 8160543 · Received December 13, 2018

    Report

    Report Number
    3008114965-2018-00823
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 28, 2018
    Report Date
    November 28, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704080275
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 1/6/2019. [ADDITIONAL INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE LEFT INTERNAL CAROTID-POSTERIOR COMMUNICATING (ICPC) ANEURYSM, AFTER THE PLACEMENT OF TWO COMPETITIVE COILS USING THE STRYKER EXCELSIOR®SL-10 STR MICROCATHETER, THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (B)(4) WAS USED AS AN ADDITIONAL COIL, AND THE COIL WAS PLACED BUT THE PHYSICIAN HAD DIFFICULTY SEEING THE POSTERIOR COMMUNICATING ARTERY AND DECIDED TO RESHEATH THE COIL. THE PHYSICIAN QUICKLY RETRACTED THE COIL AND THE COIL COULD BE PULLED ONLY HALF WAY. THE PHYSICIAN THEN REMOVED THE COIL WITH THE MICROCATHETER AND ATTEMPTED TO REMOVE THE COIL FROM THE MICROCATHETER OUTSIDE OF THE PATIENT¿S BODY BUT WAS NOT ABLE TO PUSH THE COIL OUT. THE COIL WAS THEN PULLED AND AS A RESULT, IT BECAME UNRAVELED AT THE PROXIMAL END. THE MICROCATHETER WAS REINSERTED INTO THE TARGET LESION AND ANOTHER COMPETITIVE COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO FLOW RESTRICTION OR REDUCTION REPORTED; NO ADDITIONAL INTERVENTION WAS REQUIRED. IT WAS CONFIRMED THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE TARGET SITE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION, THE REPORTED ISSUE DID NOT RESULT IN ANY PROCEDURAL DELAY. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPORTED THAT THE 2.50MM X 4.50CM GALAXY G3 MINI COIL IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE LEFT INTERNAL CAROTID-POSTERIOR COMMUNICATING (ICPC) ANEURYSM, AFTER THE PLACEMENT OF TWO COMPETITIVE COILS USING THE STRYKER EXCELSIOR®SL-10 STR MICROCATHETER, THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / L13348) WAS USED AS AN ADDITIONAL COIL, AND THE COIL WAS PLACED BUT THE PHYSICIAN HAD DIFFICULTY SEEING THE POSTERIOR COMMUNICATING ARTERY AND DECIDED TO RESHEATH THE COIL. THE PHYSICIAN QUICKLY RETRACTED THE COIL AND THE COIL COULD BE PULLED ONLY HALF WAY. THE PHYSICIAN THEN REMOVED THE COIL WITH THE MICROCATHETER AND ATTEMPTED TO REMOVE THE COIL FROM THE MICROCATHETER OUTSIDE OF THE PATIENT¿S BODY BUT WAS NOT ABLE TO PUSH THE COIL OUT. THE COIL WAS THEN PULLED AND AS A RESULT, IT BECAME UNRAVELED AT THE PROXIMAL END. THE MICROCATHETER WAS REINSERTED INTO THE TARGET LESION AND ANOTHER COMPETITIVE COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO FLOW RESTRICTION OR REDUCTION REPORTED; NO ADDITIONAL INTERVENTION WAS REQUIRED. IT WAS CONFIRMED THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE TARGET SITE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION, THE REPORTED ISSUE DID NOT RESULT IN ANY PROCEDURAL DELAY. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE 2.50MM X 4.50CM GALAXY G3 MINI COIL WAS RETURNED FOR EVALUATION AND ANALYSIS; THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 2.50MM X 4.50CM GALAXY G3 MINI COIL WAS RECEIVED CONTAINED IN A POUCH. THE RETURNED DEVICE UNDERWENT VISUAL INSPECTION. THE HUB, THE DEVICE POSITIONING UNIT (DPU) WERE OBSERVED TO BE IN GOOD CONDITION. THE MARKER BAND WAS AT 37 CM FROM THE HUB, WHICH IS CONSIDERED WITHIN SPECIFICATION. THE RESHEATHING TOOL WERE OBSERVED TO BE IN NORMAL, GOOD CONDITIONS. THE COIL INTRODUCER WAS UNZIPPED AND KINKED. THE EMBOLIC COIL WAS FOUND OUTSIDE OF THE INTRODUCER. THE DEVICE UNDERWENT MICROSCOPIC INSPECTION. THE V-NOTCH WAS FOUND IN GOOD CONDITION. THE RESISTANCE HEATING (RH) AND THE ARTICULATION JOIN WERE INSPECTED THROUGH THE MICROSCOPE THROUGH THE INTRODUCER. THE RH WAS NOT HEATED, AND THE ARTICULATION JOINT WAS IN GOOD CONDITION. THE EMBOLIC COIL WAS STRETCHED AND IN A KINKED/TANGLED CONDITION. FUNCTIONAL TESTING COULD NOT BE CONDUCTED ON THE RETURNED DEVICE DUE TO THE UNZIPPED, KINKED COIL INTRODUCER. THE CONDITION OF THE EMBOLIC COIL ALSO MADE THE DEVICE NOT ABLE TO UNDERGO EVALUATION/TESTING. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L13348) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE RESHEATHING ISSUE WITH THE COIL WAS CONFIRMED; THE COIL INTRODUCER WAS OBSERVED KINKED AND LIKELY CONTRIBUTED TO THE ISSUE ENCOUNTERED WHEN THE PHYSICIAN WAS RESHEATHING THE COIL. THE ISSUE RELATING TO THE RETRACTING OF THE COIL WAS NOT CONFIRMED WITH FUNCTIONAL EVALUATION AS THE RETURNED PRODUCT COULD NOT UNDERGO FUNCTIONAL TESTING IN THE CONDITION IT WAS RECEIVED. THE COIL INTRODUCER WAS UNZIPPED AND KINKED, AND THE EMBOLIC COIL WAS IN A STRETCHED, KINKED AND TANGLED CONDITION. THE CONDITION OBSERVED ON THE EMBOLIC COIL IS LIKELY DUE TO APPLIED EXCESSIVE FORCE; THE APPLICATION OF FORCE MAY HAVE BEEN INADVERTENT DURING PROCEDURAL HANDLING OF THE DEVICE. THE EXACT CAUSE OF THE CONDITION OF THE EMBOLIC COIL COULD NOT BE CONCLUSIVELY DETERMINED. COIL CONDITION SUCH AS STRETCHED/UNRAVELED OR KINKED ARE KNOWN POTENTIAL ISSUES ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTION FOR USE PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT ISSUES SUCH AS KINK AND STRETCHING FROM OCCURRING. THE EXACT CAUSE OF THE OBSERVED KINKED AND STRETCHED CONDITION OF THE EMBOLIC COIL COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, EXCESSIVE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED DURING THE PROCEDURAL HANDLING OF THE DEVICE AND/OR DURING THE INTERACTION WITH THE CONCOMITANT MICROCATHETER. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. IN ADDITION, DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 2.50MM X 4.50CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN THE CONDITION THAT WAS OBSERVED ON THE RETURNED DEVICE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY (B)(6) ON 1/16/2019. THE RETURNED PRODUCT IS PENDING EVALUATION; WHEN THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PROCODE IS KRD/HCG. (B)(4). CONCOMITANT MED PRODUCTS: STRYKER EXCELSIOR®SL-10 STR MICROCATHETER, STRYKER TRANSFORM® C 4MM X 10MM OCCLUSION BALLOON CATHETER. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT L13348 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE LEFT INTERNAL CAROTID-POSTERIOR COMMUNICATING (ICPC) ANEURYSM, AFTER THE PLACEMENT OF TWO COMPETITIVE COILS USING THE STRYKER EXCELSIOR®SL-10 STR MICROCATHETER, THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / L13348) WAS USED AS AN ADDITIONAL COIL, AND THE COIL WAS PLACED BUT THE PHYSICIAN HAD DIFFICULTY SEEING THE POSTERIOR COMMUNICATING ARTERY AND DECIDED TO RESHEATH THE COIL. THE PHYSICIAN QUICKLY RETRACTED THE COIL AND THE COIL COULD BE PULLED ONLY HALF WAY. THE PHYSICIAN THEN REMOVED THE COIL WITH THE MICROCATHETER AND ATTEMPTED TO REMOVE THE COIL FROM THE MICROCATHETER OUTSIDE OF THE PATIENT¿S BODY BUT WAS NOT ABLE TO PUSH THE COIL OUT. THE COIL WAS THEN PULLED AND AS A RESULT, IT BECAME UNRAVELED AT THE PROXIMAL END. THE MICROCATHETER WAS REINSERTED INTO THE TARGET LESION AND ANOTHER COMPETITIVE COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPORTED THAT THE 2.50MM X 4.50CM GALAXY G3 MINI COIL IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000165 GALAXY G3 MINI 2.5MM X 4.5CM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD SEE H.10 L13348 10886704080275

    Patients

    Seq Age Sex Outcome Treatment
    1