BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 7549746 · Received May 29, 2018

    Report

    Report Number
    9681834-2018-00091
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 6, 2018
    Report Date
    May 29, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    UDI-DI
    04987350779373
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE RESULTS OF THE DISTAL TIP FRACTURE STRENGTH TEST CONDUCTED DURING THE SHIPPING INSPECTION PROCESS WERE REVIEWED FOR PRODUCT CODE 25-1011 FOR THE PAST THREE YEARS, FROM JUNE 2015 TO MAY 2018. NO ANOMALIES WITH THE RESULTS AND NO SIGNIFICANT VARIATION IN THE DATA WERE FOUND. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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 PROVIDE ADDITION PATIENT INFORMATION AND ADDITIONAL INFORMATION. PATIENT WEIGHT- 62.2 KGS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE PATIENT PRESENTED WITH STEMI, EMERGENT LEFT HEART CATHETERIZATION IN THE CATH LAB. THE GUIDEWIRE TIP BROKE OFF INTO THE RIGHT CORONARY ARTERY. ON (B)(6) 2018 THE PATIENT HAD A DOUBLE BYPASS TO THE RIGHT CORONARY ARTERY AND THE LEFT ANTERIOR DESCENDING ARTERY. THE TIP WAS NOT SUCCESSFULLY RETRIEVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 17, 2018. DURING THE PROCEDURE THE TIP OF THE WIRE WAS SHAPED USING THE WIRE SHAPING TOOL THAT IS INCLUDED. THERE WERE NO ISSUES ADVANCING THE WIRE AND THE VESSEL WAS NOT TORTUOUS. THE WIRE DID NOT PASS THROUGH ANY STENTS. THE LESION WAS DIFFUSE AND THERE WAS NO BLOOD LOSS AT THE TIME OF THE PROCEDURE. NO OTHER PRODUCT WAS USED WITH THE WIRE. THE PATIENT REMAINED STABLE AND BYPASS SURGERY WAS REQUIRED WHERE THE PATIENT DID WELL. THE PATIENT REQUIRED TWO BYPASS SURGERIES. THE WIRE WAS REPORTED TO STILL BE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390943 RUNTHROUGH NS WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA TW*AS418XA UNK 04987350779373

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Congenital Anomaly| O