BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE SE 4.5MM OUS

    MDR report key: 7309042 · Received March 2, 2018

    Report

    Report Number
    3008114965-2018-00545
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 4, 2018
    Report Date
    February 5, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    DXE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REVIVE SE THROMBECTOMY DEVICE GOT STUCK IN THE YOGA 24 MICROCATHETER, NOT THE ¿INTRODUCER¿. THE DIFFICULTY REQUIRED THAT BOTH PRODUCTS BE REMOVED FROM THE PATIENT, RESULTING IN A LOSS OF CEREBRAL TARGET POSITION. NO APPARENT DAMAGE WAS NOTED TO THE REVIVE SE UPON REMOVAL. THERE WERE NO KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE YOGA MICROCATHETER WAS REPLACED WITH A COMPETITOR DEVICE. FORCE WAS NOT APPLIED WHEN HANDLING THE DEVICES. (B)(6). COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A THROMBECTOMY OF AN ACUTE ISCHEMIC STROKE AT THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, THE REVIVE SE 4.5MM OUS (FRS21452299/S12868) THROMBECTOMY DEVICE WAS INSERTED INTO THE YOGA 24 (MC24150Z/C42381) MICROCATHETER BUT GOT STUCK IN THE MICROCATHETER. THE DIFFICULTY REQUIRED THAT BOTH PRODUCTS BE REMOVED FROM THE PATIENT, RESULTING IN LOSS OF CEREBRAL TARGET POSITION. THE MICROCATHETER WAS REPLACED WITH A COMPETITOR DEVICE. IT IS NOT KNOWN IF THE REVIVE SE THROMBECTOMY DEVICE WAS REPLACED. THE PROCEDURE WAS DELAYED 10 MINUTES AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL WAS MILDLY TORTUOUS AND NOT CALCIFIED. AN ASAHI INTECC GUIDEWIRE AND AN OPTIMO (TOKAI MEDICAL PRODUCT) GUIDING CATHETER WERE ALSO USED FOR THE CASE. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO APPARENT DAMAGE WAS NOTED TO THE REVIVE SE UPON REMOVAL. THERE WERE NO KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. FORCE WAS NOT APPLIED WHEN HANDLING THE DEVICES. NO FURTHER INFORMATION WAS PROVIDED. THE YOGA MICROCATHETER WAS RETURNED FOR INVESTIGATION. THERE WAS A SLIGHT BEND IN THE MICROCATHETER SHAFT APPROXIMATELY 120 CM FROM THE PROXIMAL END. THERE WERE SOME BENDS IN THE DISTAL SEGMENTS OF THE MICROCATHETER. THE INNER DIAMETER (ID) OF THE MICROCATHETER WAS MEASURED AT BOTH THE DISTAL AND PROXIMAL ENDS USING PIN GAUGE SET 70123-05G. PIN GAUGES WERE VERIFIED WITH DIGITAL CALIPER 70043-01AJ BEFORE USE. THE PROXIMAL INTERNAL DIAMETER MEASURED 0.024 INCH; THE DISTAL INTERNAL DIAMETER MEASURED 0.024 INCH. BOTH DIMENSIONS ARE WITHIN THE SPECIFICATION RANGE OF =0.024 INCH. AN ATTEMPT WAS MADE TO ADVANCE THE REVIVE DEVICE FROM THIS COMPLAINT THROUGH THE YOGA MICROCATHETER. THE REVIVE DEVICE SUCCESSFULLY ADVANCED THROUGH THE YOGA MICROCATHETER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE REVIVE SE WAS RETURNED FOR INVESTIGATION. THE INTRODUCER WAS NOT RETURNED. THE BALL TIP, DISTAL COIL SECTION, AND DISTAL COIL/BASKET JUNCTION WERE INTACT. THE BASKET WAS INTACT. THERE WAS SOME BLOOD ON THE BASKET. THE PROXIMAL COIL/BASKET JUNCTION AND PROXIMAL COIL WERE INTACT. USING A PRODUCTION-RELEASED REVIVE INTRODUCER, AN ATTEMPT WAS MADE TO ADVANCE THE REVIVE DEVICE THROUGH THE YOGA DEVICE RETURNED FOR THIS COMPLAINT. THE REVIVE SUCCESSFULLY ADVANCED THROUGH THE YOGA MICROCATHETER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT THAT THE MICROCATHETER WAS OBSTRUCTED WAS NOT CONFIRMED. THE REVIVE DEVICE WAS ABLE TO SUCCESSFULLY PASS THROUGH THE ENTIRE MICROCATHETER. THE COMPLAINT THAT THE REVIVE WAS IMPEDED IN THE MICROCATHETER WAS NOT CONFIRMED. THE TEST WAS MADE WITH THE DEVICE AND MICROCATHETER USED DURING THE REPORTED EVENT. THE ORIGINAL REVIVE INTRODUCER WAS NOT RETURNED, AND A REPLACEMENT PRODUCTION RELEASED INTRODUCER WAS USED TO CONDUCT THE TEST. WITHOUT THE RETURN OF THE INTRODUCER, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NEITHER THE DEVICE HISTORY RECORD REVIEWS NOR THE PRODUCT ANALYSES SUGGEST THAT THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNITS. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, IT APPEARS THAT CIRCUMSTANCES OF THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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 EVENTS WERE 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00544 &3008114965-2018-00545.

    Additional Manufacturer Narrative · 1

    (B)(4) REVIVE SE IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IT IS SIMILAR TO THE REVIVE PV THAT IS DISTRIBUTED IN THE U.S. INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WERE NOT PROVIDED. THE PRODUCT HAS NOT YET BEEN RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. (B)(4). CONCOMITANT MEDICAL PRODUCTS - ASAHI INTECC GUIDEWIRE, OPTIMO (TOKAI MEDICAL PRODUCT) GUIDING CATHETER, YOGA 24, 0.024" ID, 150 CM (MC24150Z/C42381) MICROCATHETER. INITIAL REPORTER - THE CUSTOMER CONTACT INFORMATION WAS NOT PROVIDED. (B)(4). 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 TWO PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00544 AND 3008114965-2018-00545.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A THROMBECTOMY OF AN ACUTE ISCHEMIC STROKE AT THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, THE REVIVE SE 4.5 MM OUS (FRS21452299/S12868) THROMBECTOMY DEVICE WAS INSERTED INTO THE YOGA 24 (MC24150Z/C42381) MICROCATHETER BUT GOT STUCK IN THE ¿INTRODUCER¿. THE DEVICE WAS REPLACED WITH A COMPETITOR DEVICE. THE PROCEDURE WAS DELAYED 10 MINUTES AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL WAS MILDLY TORTUOUS AND NOT CALCIFIED. AN ASAHI INTECC GUIDEWIRE AND AN OPTIMO (TOKAI MEDICAL PRODUCT) GUIDING CATHETER WERE ALSO USED FOR THE CASE. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE PRODUCTS WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154742 REVIVE SE 4.5MM OUS EMBOLECTOMY CATHETER DXE REFER TO SECTION H10 S12868

    Patients

    Seq Age Sex Outcome Treatment
    1