BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 7310811 · Received March 2, 2018

    Report

    Report Number
    2024168-2018-01527
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    December 19, 2017
    Report Date
    March 2, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    UDI-DI
    08717648037801
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT MANIPULATION AND/OR INTERACTION WITH THE MODERATELY CALCIFIED ANATOMY AND/OR OTHER DEVICES RESULTED IN THE REPORTED BREAK AND REPORTED STRETCHED COILS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT RECEIVED STATES, ON (B)(6) 2017 AT 12:00 IN GSH CATH LAB 1 WE HAD A STEMI WITH DR. (B)(6) ((B)(6) 2017 @ 1141). DR. (B)(6) USED AN 0.014 WHISPER MS WIRE TO DELIVER THE APPROPRIATE BALLOONS AND STENTS TO OPEN UP A BLOCKED RIGHT CORONARY ARTERY. DURING THE STEMI THE TIP OF THE WIRE BECAME UNCOILED, YET STAYED INTACT. WE DID NOT LOSE ANY OF THE WIRE IN THE PATIENT'S BODY. DUE TO THE WIRE COMING APART. DR. (B)(6) HAD TO REMOVE THE DEFECTIVE EQUIPMENT AND REPLACE IT. THIS ADDED UNNECESSARY TIME AND RISK TO THE STEMI PATIENT AND EFFECTED THE TIMELESS OF CARE. FOLLOW-UP INFORMATION REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MODERATE CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO RESISTANCE NOTED EITHER DIRECTION. THEY DON'T KNOW WHAT CAUSED IT TO UNCOIL. ANOTHER WHISPER GUIDE WIRE WAS USED TO FINISH THE PROCEDURE WITH GOOD OUTCOME. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154618 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 7072671 08717648037801

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR