BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 8105342 · Received November 27, 2018

    Report

    Report Number
    9681834-2018-00208
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 23, 2018
    Report Date
    November 27, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON, EVALUATION CODE 11 HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION OF H6. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT FILE. A REVIEW OF THE RECORDS RELEVANT TO THE INVOLVED PRODUCT CODE WAS CONDUCTED. THE RESULTS OF THE DISTAL TIP RIGIDNESS TEST PERFORMED IN THE SHIPPING INSPECTION PROCESS WERE REVIEWED BACK FOR THE PAST THREE YEARS (FROM DECEMBER 2015 TO NOVEMBER, 2018) FROM THE MONTH OF OCCURRENCE OF THIS COMPLAINT WITH NO FINDINGS. THE RESULTS OF THE MEASUREMENT OF THE OUTSIDE DIAMETER OF THE RADIOPAQUE MARKER ON THE PLATINUM COIL SECTION WERE REVIEWED BACK FOR THE PAST THREE YEARS (FROM DECEMBER 2015 TO NOVEMBER, 2018) FROM THE MONTH OF OCCURRENCE OF THIS COMPLAINT WITH NO FINDINGS. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION AND PROVIDE THE COMPLETED INVESTIGATION RESULTS. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS AVAILABLE FOR EVALUATION, HOWEVER, THE DEVICE HAS BECOME NO LONGER AVAILABLE AND WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF THE USER FACILITY INFORMATION AND FIVE RETENTION SAMPLES FROM THE INVOLVED PRODUCT CODE/LOT NUMBERS, (B)(4), WHICH WERE MANUFACTURED ON DAYS BEFORE AND CLOSE TO THE DATE OF OCCURRENCE OF THIS INCIDENT, WERE PULLED OUT AND EVALUATED RESPECTIVELY AS FOLLOWS. VISUAL INSPECTION DID NOT FIND ANY ANOMALY IN THE APPEARANCE ALONG THE TOTAL LENGTH. MAGNIFYING INSPECTION OF THE PLATINUM COIL SECTION FROM 0 TO APPROXIMATELY 30MM FROM THE DISTAL END REVEALED NO ANOMALY, INCLUDING IRREGULARITY IN THE COIL PITCH. THE APPEARANCE WAS VERIFIED TO BE COMPARABLE TO THAT OF THE RETENTION SAMPLE OF THE INVOLVED PRODUCT CODE/DIFFERENT LOT# COMBINATION. MAGNIFYING INSPECTION FOCUSING ON THE DISTAL TIP DID NOT REVEAL ANY ANOMALY, INCLUDING BURRS OR DEFORMITY. IT WAS VERIFIED TO BE COMPARABLE TO THAT OF THE RETENTION SAMPLE OF THE INVOLVED PRODUCT CODE/DIFFERENT LOT# COMBINATION. MAGNIFYING INSPECTION OF THE STAINLESS STEEL COIL SECTION REVEALED NO ANOMALY, INCLUDING IRREGULARITY IN THE COIL PITCH, IN THE APPEARANCE. THE OUTSIDE DIAMETERS OF THE PLATINUM COIL AND STAINLESS STEEL COIL SECTIONS WERE CONFIRMED TO BE WITHIN MANUFACTURER SPECIFICATIONS. THE INVESTIGATION RESULTS VERIFY THE SAMPLES FROM THE FIVE PRODUCT CODE/LOT# COMBINATIONS WERE CONFIRMED TO BE THE NORMAL PRODUCTS, NOT PRESENTING ANY ANOMALIES WHICH COULD HAVE BEEN A TRIGGER OF A VESSEL PERFORATION. HOWEVER, WITH THE ABSENCE OF THE ACTUAL SAMPLES TO BE EVALUATED, THE CAUSE OF OCCURRENCE OF THE REPORTED EVENTS CANNOT BE DEFINITELY DETERMINED FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE PATIENT INCURRED A PERFORATION WHEN THE INVOLVED RUNTHROUGH NS DEVICE WAS USED. THE EVENT OCCURRED DURING A CRTD IMPLANT. THE PHYSICIAN, AFTER IMPLANTING A DURATA 7122Q/58, SN (B)(4) AND A TENDRIL STS 2088TC/52, SN (B)(4), CANNULATED THE CS USING AN EP CATHETER (JSN REF. 401430 6F QUAD-120 CM); THEN HE RAN A SLITTABLE DELIVERY (CPS 2 SL 135 DS2C003) OVER THE EP CATHETER AND INTRODUCED A VENOGRAM CATHETER (CORODYN P1 80 CM REF. 601284) TO SEE ALL THE AVAILABLE VEINS TO PLACE THE LV LEAD. AFTER THE VENOGRAM HE ASKED A QUARTET 1456Q/86, SN (B)(4) AND A TERUMO RUNTHROUGH NS INTERMEDIATE (REF. TW-DS418IA) TO IMPLANT THE LEAD "OVER THE WIRE". THE ACCESS TO THE LATERAL VEIN WAS VERY DIFFICULT SO HE ENTERED IN A POSTERIOR VEIN BUT PACING THRESHOLDS WERE VERY HIGH AND THE PATIENT HAD PNS ON EACH VECTOR. SO, HE DECIDED TO COME BACK ON THE FIRST ATTEMPT. WHILE THE PHYSICIAN TRIED TO ENTER THE VEIN WITH GUIDE + QUARTET HE NOTED THAT THE MAXIMUM ARTERIAL PRESSURE REACHED 60 MMHG SO HE DECIDED TO PERFORM AN ABDOMEN ULTRASOUND ECHO: THERE WAS DEPOSIT IN THE PERICARDIUM. SO, THE PHYSICIAN SUSPECTED A BREACH IN THE CS DUE TO THE NUMEROUS GUIDE COLLISIONS AND BEGAN TO DRAIN THE BLOOD WITH PERICARDIOCENTESIS. IN THE MEANWHILE, HE CALLED THE CARDIO SURGEON AND DECIDED TO CLOSE THE IMPLANT WITH A DUAL CHAMBER ICD: ELLIPSE DR CD2377-36QC, SN (B)(4). THE PATIENT WAS ASLEEP AND HER CIRCULATORY SYSTEM CONNECTED TO ECC. THE CARDIO SURGEON PERFORMED A THORACOTOMY AND IN FEW MINUTES CLOSED THE BREACH (UNDER THE LEFT ATRIUM). AT THE END OF THE PROCEDURE THE ANESTHESIOLOGIST TRIED TO WAKE THE PATIENT UP BUT SHE WAS BLEEDING FROM THE MOUTH. AT THE ECHO THEY SAW THAT THE RVOT WAS COMPLETELY CLOSED AND THE MAXIMUM ARTERIAL PRESSURE DROP AGAIN TO 70MMHG SO THE CARDIO SURGEON DECIDED TO RE-OPEN THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM. DURING THE PROCEDURE, NO FURTHER BREACHES WERE FOUND SO THE CARDIO SURGEON FINALLY STATED THAT THE REASON OF HER LOW PRESSURE WAS ONLY THE ANTICOAGULANT THERAPY. THE WOUND WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE. TODAY THE PATIENT HAS AWAKENED AND HER CONDITIONS ARE GOOD. THE PRESSURE NOW CAME BACK IN THE NORMAL RANGE AND IS STABLE. THE PROCEDURE OUTCOME IS "UNKOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947257 RUNTHROUGH NS WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other