BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXSFT10 1.5MM X 2CM

    MDR report key: 12516122 · Received September 22, 2021

    Report

    Report Number
    3008114965-2021-00472
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 21, 2021
    Report Date
    October 22, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077251
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE FAILURE DID NOT OCCUR DURING PRE-DEPLOYMENT ELECTRICAL CHECK. THE SAME DETACHABLE CONTROL BOX (DCB) WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE SAME CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. NO NECK REMODELING WAS UTILIZED. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL WAS NOT STRETCHED OR DAMAGED WHEN REMOVED. THE TARGET VESSEL/SITE BEING TREATED WAS THE MIDDLE CEREBRAL ARTERY (MCA). NO RELEVANT ANATOMICAL INFORMATION WAS REPORTED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE MIDDLE CEREBRAL ARTERY (MCA), A DELTAXSFT10 1.5MM X 2CM COIL (DLX100152, K10016) FAILED TO DETACH. IT WAS RETRACTED FULLY AND REPLACED WITH ANOTHER COIL. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE FAILURE DID NOT OCCUR DURING PRE-DEPLOYMENT ELECTRICAL CHECK. THE SAME DETACHABLE CONTROL BOX (DCB) WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE SAME CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. NO NECK REMODELING WAS UTILIZED. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL WAS NOT STRETCHED OR DAMAGED WHEN REMOVED. NO RELEVANT ANATOMICAL INFORMATION WAS REPORTED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE K10016 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT OF ¿COIL - FAILURE TO DETACH¿ COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING RECORD EVALUATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. CONTRIBUTED TO THE REPORTED FAILURE. FAILURE TO DETACH IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL PRECAUTIONS RELATED TO THIS ISSUE AND INCLUDES INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICE; 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 ISSUE. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 1.5MM X 2CM COIL (DLX100152, K10016) FAILED TO DETACH. IT WAS RETRACTED FULLY AND REPLACED WITH ANOTHER COIL. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409197 DELTAXSFT10 1.5MM X 2CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL DLX100152 K10016 10886704077251

    Patients

    Seq Age Sex Outcome Treatment
    1