BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID GUIDEWIRE

    MDR report key: 10663401 · Received October 12, 2020

    Report

    Report Number
    3014162263-2020-00027
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    August 29, 2018
    Report Date
    October 8, 2020
    Manufacturer
    BALT EXTRUSION
    Product Code
    MOF
    PMA / PMN Number
    K182337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BALT USA HAS ALIGNED THE UNITED STATES MANDATORY REPORTING PROCESS WITH BALT EXTRUSION. UNDER THIS IMPROVED REPORTING PROCESS, "SIMILAR DEVICES" BETWEEN BALT EXTRUSION AND BALT USA HAVE BEEN DEFINED. ALL COMPLAINTS RECEIVED BY BALT EXTRUSION AND RELATED TO SUCH SIMILAR DEVICES WHICH ARE MARKETED IN THE UNITED STATES BY BALT USA SHALL BE EVALUATED BY BALT USA ACCORDING TO MDR REQUIREMENTS. A RETROACTIVE ANALYSIS WAS PERFORMED ON LEGACY COMPLAINT RECORDS TO IDENTIFY ANY PRIOR OCCURRENCES DEEMED MDR REPORTABLE. THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE UNDER THIS PROGRAM AND RECORDED IN THE BALT USA COMPLAINT MANAGEMENT SYSTEM. BALT USA'S REFERENCE NUMBER: (B)(4). HERE IS THE SUMMARY OF EVENT AND INVESTIGATION AS REPORTED BY BALT EXTRUSION: "END BROKEN IN THE PATIENT NO PATIENT INJURY." THE RETURNED PRODUCT WAS INSPECTED IN OUR QUALITY LABORATORY. DURING OUR ANALYSIS, WE NOTED THAT THE GUIDEWIRE WAS RUPTURED AT THE LEVEL OF THE WELDING BETWEEN THE NITINOL AND THE STAINLESS STEEL PART. NO ANOMALY WAS OBSERVED ON BOTH PARTS OF THE WELDING. RATIO HYBRID RUPTURE NITINOL-INOX DURING USE: 2016: 1 (28962) -> 0.0035%, 2017: 2 (33345) -> 0.006%, 2018: 1 (21798) -> 0.005%. THE REVIEW OF THE DHR (DEVICE HISTORY RECORD) DID NOT HIGHLIGHT ANY ANOMALY DURING THE MANUFACTURING PROCESS. THE CONTROLS PERFORMED ON THE WELDING CONFORMED TO THEIR SPECIFICATIONS. FURTHERMORE, THE WELDING PROCESS IS VALIDATED AND NO ANOMALY IS OBSERVED TO DATE ON THE PERIODIC MONITORING. NO OTHER COMPLAINT IS REGISTERED ON THIS BATCH NUMBER TO DATE. GENERALLY, THIS KIND OF ISSUE CAN OCCUR DURING THE MANIPULATION DUE TO AN EXCESSIVE TRACTION, BENDING OR TWISTING OF THE DEVICE. AS MENTIONED IN THE IFU (SEE § 5. "DIRECTIONS FOR USE" AND § 6.1 "PRECAUTIONS FOR USE"): "AVOID REPEATED BENDING, AT THE SAME POINT IN ORDER TO AVOID DAMAGE OR SEPARATION OF THE GUIDEWIRE"; "REMOVE THE GUIDEWIRE SLOWLY ONCE THE GOAL HAS BEEN REACHED"; "NEVER FORCE AN INTRAVASCULAR DEVICE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE THROUGH ANGIOGRAPHIC INSPECTION. WORKING AGAINST RESISTANCE CAN DAMAGE THE GUIDEWIRE AND THE CATHETER OR CAUSE LESIONS IN THE PATIENT". NEVERTHELESS, AS DESCRIBED IN THE INCIDENT DESCRIPTION, NO SPECIFIC FORCE WAS APPLIED DURING THE PROCEDURE AND THERE WAS NO TORTUOUS VESSEL DURING THE NAVIGATION. AS A RESULT, WE CANNOT ACCURATELY DETERMINE THE ORIGIN OF THE INCIDENT. NO ANOMALY WAS OBSERVED ON THE DEVICE NOR ON THE MANUFACTURING AND CONTROLS RECORDS. THE PROCEDURE CONDITIONS DESCRIBED DO NOT HIGHLIGHT ANY DIFFICULTY THAT COULD POTENTIALLY EXPLAIN THE ISSUE EXPERIENCED BY THE USER. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. THIS ISSUE WILL REMAIN SUBJECT TO CONTINUED TRACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "END BROKEN IN THE PATIENT NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131698 HYBRID GUIDEWIRE HYBRID MOF BALT EXTRUSION HYBRID007D 00327614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention