BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 16271918 · Received January 31, 2023

    Report

    Report Number
    2024168-2023-00996
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 3, 2023
    Report Date
    April 13, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648138416
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED BALLOON RUPTURE WAS UNABLE TO BE CONFIRMED; HOWEVER, THE GUIDE WIRE EXIT NOTCH WAS TORN AND LEAKED WHICH IS LIKELY WHAT THE ACCOUNT PERCEIVED AS THE REPORTED BALLOON RUPTURE. 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 SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE NOTED TEAR IN THE GUIDE WIRE EXIT NOTCH, LEAK AND REPORTED BALLOON RUPTURE APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D10/H3: RETURN STATUS UPDATED H6: COMPONENT CODES ADDED: 4761, 3123, 525, 829. H6: TYPE OF INVESTIGATION CODES: 4111, 3331, 4109, 4115 REMOVED; 10 ADDED.. H6: INVESTIGATION FINDINGS: 3221 REMOVED; 114 ADDED. H6: INVESTIGATION CONCLUSIONS CODES: 4315 REMOVED; 4307 ADDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.0X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS NOTED TO HAVE BROKEN [RUPTURED] DURING THE PROCEDURE PRESENTING THE PATIENT WITH A RISK OF GAS EMBOLISM. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005399 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012449-08 10811G1 08717648138416

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown