BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT VERSATURN GUIDE WIRE

    MDR report key: 17191964 · Received June 23, 2023

    Report

    Report Number
    2024168-2023-06672
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 27, 2023
    Report Date
    September 13, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648198496
    PMA / PMN Number
    K141782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE CORE WAS SEPARATED DISTAL TO THE CENTER SOLDER, BUT THE GUIDE WIRE REMAINED IN ONE PIECE. THE REPORTED PEELED/DELAMINATED COULD NOT BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT THE GUIDE WIRE BREAK NOTED DURING RETURN ANALYSIS WAS INADVERTENTLY REPORTED AS DELAMINATED, BUT THIS COULD NOT BE CONFIRMED. THE REPORTED DIFFICULT TO ADVANCE COULD NOT BE TESTED DUE TO THE DEVICE CONDITION. 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/COMPLAINTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED PEELED/DELAMINATED. THE REPORTED DIFFICULT TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. H3, H10: THE DEVICE WAS RETURNED FOR ANALYSIS. H6: TYPE OF INVESTIGATION CODE 4114 WAS REMOVED. H6: INVESTIGATION CONCLUSIONS CODE 4315 WAS REMOVED.

    Additional Manufacturer Narrative · 0

    THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART/LOT NUMBERS WERE NOT REPORTED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE VERSATURN GUIDEWIRE(B)(4) (GW) WAS ATTEMPTED TO BE USED IN A PROCEDURE; HOWEVER, THE GW MET WITH RESISTANCE WITH THE CATHETER. THEREFORE, THE GW WAS REMOVED FROM THE PATIENT AND DELAMINATION [PEELING] WAS NOTED ON THE GW. ANOTHER GW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000709 HT VERSATURN GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 3031071 08717648198496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown