BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 CERE 7MMX30CM

    MDR report key: 8019876 · Received October 30, 2018

    Report

    Report Number
    3008114965-2018-00778
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 3, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    HCG
    UDI-DI
    00878528003038
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). UPDATED SECTIONS: DATE REC¿D BY MFR, PMA/510K, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MFR. [COMPLAINT CONCLUSION]: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE USER ENCOUNTERED RESISTANCE WHILE ADVANCING THE 6MM X 26CM PRESIDIO 10 CERE (PC410062630/S10208), 7MM X 30CM PRESIDIO 10 CERE (PC410073030/S10163), AND THE 7MM X 20CM MICRUSPHERE XL (SSR10072020/S13782) THROUGH THE PROXIMAL SHAFT OF THE PROWLER SELECT PLUS (606S255X/17674174) MICROCATHETER. THE ISSUE REQUIRED THAT THE COILS BE REMOVED AND REPLACED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS DELAYED LESS THAN 30 MINUTES DUE TO THE EVENT. THE DEVICES WERE PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE CONCOMITANT MICROCATHETER DID NOT APPEAR DAMAGED. A 10MM X 34CM PRESIDIO COIL AND COMPETITOR COILS WERE USED SUCCESSFULLY WITH THE CONCOMITANT MICROCATHETER PRIOR TO AND FOLLOWING THE ENCOUNTERED RESISTANCE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL PORTION OF THE 6MM X 26CM PRESIDIO EMBOLIC COIL WAS KINKED, THE DISTAL PORTION OF THE 7MM X 30CM PRESIDIO EMBOLIC COIL WAS STRETCHED, AND THE DISTAL PORTION OF THE 7MM X 20CM MICRUSPHERE EMBOLIC COIL WAS BENT WHEN THE PRODUCTS WERE REMOVED FROM THE PATIENT. NO FURTHER INFORMATION COULD BE OBTAINED. THE 7MM X 30CM PRESIDIO 10 WAS RETURNED WITH ITS ORIGINAL LABEL THAT MATCHED THE COMPLAINT INFORMATION. KINKS WERE OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE APPROXIMATELY 91 CM FROM THE PROXIMAL END OF THE DEVICE. THE DISTAL END OF THE EMBOLIC COIL WAS SEEN IN THE TRANSLUCENT INTRODUCER SHEATH. THE FLEXIBLE, DISTAL END OF THE DPU CORE WIRE WAS SEEN PROTRUDING AND RE-ENTERING THE INTRODUCER SKIVE. THE COIL SUBSEQUENTLY COULD NOT BE ADVANCED FROM THE INTRODUCER SHEATH. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. NO DAMAGE OR STRETCHING WAS OBSERVED ON THE EMBOLIC COIL. THE PROXIMAL END OF THE EMBOLIC COIL WAS SEEN PRESSED INTO THE DISTAL END OF THE DISTAL OUTER SHEATH, DAMAGING THE ARTICULATING JOINT. THE VIEW OF THE DISTAL OUTER SHEATH WAS OBSCURED BY BLOOD STAINS ON THE INTRODUCER WALL. NO BLOOD WAS SEEN ON THE EMBOLIC COIL. THE FLEXIBLE, DISTAL END OF THE DPU CORE WIRE APPEARED TO BE TWISTED WHERE IT PROTRUDED FROM THE SKIVE. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT: S10163 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 THAT THE EMBOLIC COIL WAS STRETCHED WAS NOT CONFIRMED. NO DAMAGE OR STRETCHING WAS SEEN ON THE EMBOLIC COIL WHEN OBSERVED UNDER A MICROSCOPE. THE REPORTED CUSTOMER COMPLAINT OF RESISTANCE/FRICTION DURING ADVANCEMENT THROUGH THE MICROCATHETER COULD NOT BE CONFIRMED SINCE THE COIL WAS IMPEDED IN THE INTRODUCER. THE COIL WAS IMPEDED IN THE INTRODUCER DUE TO THE PROTRUSION OF THE FLEXIBLE PART OF THE DPU CORE WIRE. THEREFORE, THE DEVICE'S ABILITY TO ADVANCE THROUGH A MICROCATHETER COULD NOT BE TESTED. HOWEVER, SINCE DESCRIPTION OF COIL DAMAGE WAS REPORTED BY THE CUSTOMER, THE DEVICE HAD INITIALLY EXITED THE INTRODUCER TO VISUALIZE THE EMBOLIC COIL. THE MICROCATHETER USED DURING THE PROCEDURE WAS NOT RETURNED FOR FAILURE ANALYSIS. THERE IS NOT ENOUGH INFORMATION TO IDENTIFY THE CAUSE OF THE OBSERVED FAILURE. HOWEVER, IT IS LIKELY THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE ARTICULATING JOINT WAS COMPRESSED AND THE DPU CORE WIRE WAS PROTRUDING FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH, INDICATING THAT FORCE WAS APPLIED WHILE THE DEVICE WAS PREVENTED FROM ADVANCING. 100% OF DEVICES ARE VERIFIED FOR PROPER MOVEMENT OF THE DPU CORE WIRE AND COIL THROUGH THE INTRODUCER SHEATH. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGES. RESISTANCE/FRICTION DURING ADVANCEMENT AND DAMAGE TO THE EMBOLIC COIL ARE KNOWN POTENTIAL PRODUCT FAILURES 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. PER THE IFU, ¿IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM THROUGH THE INTRODUCER, OPEN THE RHV MAIN VALVE, AND PARTIALLY WITHDRAW THE DISTAL END OF THE INTRODUCER TO EXPOSE ITS TIP WITHIN THE RHV. TIGHTEN THE RHV MAIN VALVE,AND FLUSH THE Y-CONNECTOR OF THE RHV WITH STERILE SALINE AND VERIFY THAT FLUID EXITS THE SLIT IN THE CLEAR PORTION OF THE INTRODUCER. LOOSEN THE RHV MAIN VALVE AND FULLY RE INSERT THE INTRODUCER TIP INTO THE INFUSION MICROCATHETER HUB. GENTLY TIGHTEN THE RHV MAIN VALVE AROUND THE INTRODUCER SHEATH TO PREVENT BACKFLOW OF BLOOD. VISUALLY INSPECT THE ALIGNMENT OF THE INTRODUCER TIP AND THE MICROCATHETER HUB TO ENSURE THEY HAVE NOT SLIPPED APART. IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM AND EXAMINE FOR DAMAGE. REPLACE IT WITH A NEW MICROCOIL SYSTEM.¿ THE RETURNED DEVICE DOES NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE EVENT AS REPORTED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE MINIMAL INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE SAMPLE ARTICLE; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS, INCLUDING DEVICE MANIPULATION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00777 & 3008114965-2018-00779.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BASED ON THE PRODUCT DAMAGE REPORTED ON 10/15/2018, THIS EVENT MEETS THE REQUIRED CRITERIA FOR MDR REPORTING. INFORMATION REGARDING PATIENT DATE OF BIRTH, 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 MEDICAL PRODUCTS DUE TO CHARACTER LIMITATION: PROWLER SELECT PLUS (606S255X/17674174) MICROCATHETER. INITIAL REPORTER PHONE: (B)(6). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00777 & 3008114965-2018-00779.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE USER ENCOUNTERED RESISTANCE WHILE ADVANCING THE 6MM X 26CM PRESIDIO 10 CERE (PC410062630/C35483), 7MM X 30CM PRESIDIO 10 CERE (PC410073030/S10163), AND THE 7MM X 20CM MICRUSPHERE XL (SSR10072020/S13782) THROUGH THE PROXIMAL SHAFT OF THE PROWLER SELECT PLUS (606S255X/17674174) MICROCATHETER. THE ISSUE REQUIRED THAT THE COILS BE REMOVED AND REPLACED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURAL DELAY WAS LESS THAN 30 MINUTES. THE DEVICES WERE PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE CONCOMITANT MICROCATHETER DID NOT KINK OR BEND AT ANY TIME. A 10MM X 34CM PRESIDIO COIL AND COMPETITOR COILS WERE USED SUCCESSFULLY WITH THE CONCOMITANT MICROCATHETER PRIOR TO AND FOLLOWING THE ENCOUNTERED RESISTANCE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL PORTION OF THE 6MM X 26CM PRESIDIO EMBOLIC COIL WAS KINKED, THE DISTAL PORTION OF THE 7MM X 30CM PRESIDIO EMBOLIC COIL WAS STRETCHED, AND THE DISTAL PORTION OF THE 7MM X 20CM MICRUSPHERE EMBOLIC COIL WAS BENT WHEN THE PRODUCTS WERE REMOVED FROM THE PATIENT. THE COMPLAINT PRODUCTS WILL BE RETURNED FOR ANALYSIS. THE CONCOMITANT MICROCATHETER IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859313 PRESIDIO 10 CERE 7MMX30CM NEUROVASCULAR EMBOLIZATION DEVICE HCG REFER TO SECTION H10 S10163 00878528003038

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR