BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXSFT10 2.5MM X 6CM

    MDR report key: 8027637 · Received November 1, 2018

    Report

    Report Number
    3008114965-2018-00784
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    August 7, 2018
    Report Date
    August 8, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077282
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BASED ON THE EMBOLIC COIL DAMAGE NOTED DURING THE PRODUCT INVESTIGATION, THIS EVENT MEETS THE REQUIRED CRITERIA FOR MDR REPORTING. INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT PROVIDED. PROCODE: KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). CONCOMITANT MED PRODUCTS (DUE TO CHARACTER LIMITATION): PROWLER SELECT LPES 45 DEG TIP MICROCATHETER (606S155FX/17769648). INITIAL REPORTER PHONE: (B)(6). [COMPLAINT CONCLUSION]: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, THE SURGEON INSERTED THE 2.5MM X 6CM DELTAXSFT10 (DLX100256/L11405) THERMO-MECHANICAL COIL INTO THE PROWLER SELECT LPES 45 DEG TIP (606S155FX/17769648) BUT THE COIL COULD ONLY BE ADVANCED APPROXIMATELY 10 CENTIMETERS (CM). THE COIL WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH A NEW COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME MICROCATHETER AND SPECTRA COILS. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE ISSUE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. POST-PROCEDURE, THE SURGEON ATTEMPTED TO ADVANCE THE COMPLAINT COIL INTO THE MICROCATHETER AND ENCOUNTERED THE SAME ISSUE. OTHER PRODUCTS WERE USED SUCCESSFULLY WITH THE CONCOMITANT MICROCATHETER PRIOR TO THE ENCOUNTERED RESISTANCE. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. THE CONCOMITANT MICROCATHETER WAS NOT DAMAGED IN ANY WAY. THE PRODUCT WAS PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE VESSEL DID NOT HAVE ACUTE BENDS OR EXCESSIVE TORTUOSITY. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED WITH THE ORIGINAL PACKAGING LABEL, WHICH MATCHED THE COMPLAINT INFORMATION. THE DEVICE WAS RETURNED UNSHEATHED AS INDICATED BY THE LENGTH OF THE INTRODUCER PROXIMAL TO THE RESHEATHING TOOL. THE DISTAL TIP OF THE EMBOLIC COIL WAS OBSERVED TO BE IN THE TRANSLUCENT INTRODUCER. NO KINKS WERE OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE. THE DEVICE WAS THEN OBSERVED UNDER A MICROSCOPE. THE EMBOLIC COIL WAS SEEN TO BE KINKED AT MULTIPLE POINTS ALONG ITS LENGTH. THE EMBOLIC COIL WAS STRETCHED AT ITS PROXIMAL END. THE ARTICULATING JOINT WAS SEEN INTACT IN THE INTRODUCER. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE SKIVE OF THE INTRODUCER HAD A WIDENED GAP WHERE THE EMBOLIC COIL WAS KINKED. THE DEVICE WAS ADVANCED THROUGH A LAB PROWLER SELECT LP MICROCATHETER. THE DISTAL END OF THE COIL WAS ADVANCED; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE COIL BECAME STUCK AND COULD NOT FULLY BE ADVANCED THROUGH THE CATHETER. THE DEVICE WAS REMOVED FROM THE CATHETER AND INSPECTED UNDER A MICROSCOPE, ADVANCED FROM THE INTRODUCER. THE EMBOLIC DISTAL BALL TIP WAS PRESENT AND INTACT. THE DISTAL OUTER SHEATH HAD NOT SOFTENED, INDICATING THAT THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. THE ARTICULATING JOINT WAS SEEN INTACT. THE PROXIMAL END OF THE EMBOLIC COIL WAS SEEN STRETCHED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 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 REPORTED CUSTOMER COMPLAINT OF IMPEDED IN MICROCATHETER WAS CONFIRMED. AN ATTEMPT WAS MADE TO ADVANCE THE DEVICE THROUGH A LAB PROWLER SELECT LP MICROCATHETER, WHICH RESULTED IN THE EMBOLIC COIL UNABLE TO COMPLETELY EXIT THE DISTAL END OF THE MICROCATHETER. THE FAILURE TO ADVANCE WAS LIKELY DUE TO THE KINKS AND STRETCHING IN THE EMBOLIC COIL, WHICH CAN CAUSE THE COIL TO MOVE AT AN ANGLE AND RUB AGAINST THE INNER WALLS OF THE MICROCATHETER RESULTING IN IMPEDANCE OF THE COIL. THERE IS NOT ENOUGH INFORMATION IN THE COMPLAINT TO IDENTIFY THE CAUSE OF THE KINKS IN THE EMBOLIC COIL. HOWEVER, THE KINKS IN THE COIL AND GAP IN THE SKIVE OF THE INTRODUCER MAY HAVE BEEN THE RESULT OF EXCESSIVE FORCE WHEN INTRODUCING THE DEVICE INTO THE DELIVERY SYSTEM OR RETRIEVAL FROM THE PACKAGE HOOP. THE CONCOMITANT MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED AND COULD NOT BE ANALYZED. IN ADDITION, THE STRETCHING OF THE PROXIMAL END OF THE EMBOLIC COIL WAS LIKELY FROM EXCESSIVE PULL FORCE APPLIED TO THE DEVICE WHEN RETRACTING THE DELIVERY SYSTEM. 100% OF DEVICES ARE INSPECTED FOR DAMAGE TO THE EMBOLIC COIL IN-PROCESS. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE. IMPEDED IN MICROCATHETER IS A KNOWN POTENTIAL PRODUCT FAILURE 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. NEITHER THE PRODUCT ANALYSIS NOR THE DEVICE HISTORY RECORD REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS, INCLUDING DEVICE MANIPULATION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES NOTED ON THE RETURNED SYSTEM. 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.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, THE SURGEON INSERTED THE 2.5MM X 6CM DELTAXSFT10 (DLX100256/L11405) THERMO-MECHANICAL COIL INTO THE PROWLER SELECT LPES 45 DEG TIP (606S155FX/17769648) BUT THE COIL COULD ONLY BE ADVANCED APPROXIMATELY 10 CENTIMETERS (CM). THE COIL WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH A NEW COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME MICROCATHETER AND SPECTRA COILS. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE ISSUE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. POST-PROCEDURE, THE SURGEON ATTEMPTED TO ADVANCE THE COMPLAINT COIL INTO THE MICROCATHETER AND ENCOUNTERED THE SAME ISSUE. OTHER PRODUCTS WERE USED SUCCESSFULLY WITH THE CONCOMITANT MICROCATHETER PRIOR TO THE ENCOUNTERED RESISTANCE. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. THE CONCOMITANT MICROCATHETER WAS NOT DAMAGED IN ANY WAY. THE PRODUCT WAS PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE VESSEL DID NOT HAVE ACUTE BENDS OR EXCESSIVE TORTUOSITY. EVALUATION OF THE RETURNED PRODUCT REVEALED EMBOLIC COIL DAMAGE. THE CONCOMITANT MICROCATHETER IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867606 DELTAXSFT10 2.5MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 L11405 10886704077282

    Patients

    Seq Age Sex Outcome Treatment
    1