BEUDAMED
    FDA Adverse Event Death Summary report: N

    NC TREK RX

    MDR report key: 9727825 · Received February 19, 2020

    Report

    Report Number
    2024168-2020-01609
    Event Type
    Death
    Date Received
    February 19, 2020
    Date of Event
    January 23, 2020
    Report Date
    April 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648152085
    PMA / PMN Number
    K103153
    Removal / Correction Number
    Z-1133-2020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED ONE MANUFACTURING NONCONFORMITY ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED ONE SIMILAR COMPLAINT FROM THIS LOT WHICH IS ASSOCIATED WITH AN EXCEPTION. THE INVESTIGATION DETERMINED THE REPORTED DEFLATION ISSUE IS RELATED TO A MANUFACTURING ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF DEATH, PERFORATION AND OCCLUSION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. FURTHERMORE, THE ADDITIONAL TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. ON JANUARY 15, 2020, THE ABBOTT VASCULAR DETERMINED THAT A FIELD SAFETY CORRECTIVE ACTION IS REQUIRED FOR SPECIFIC LOTS OF NC TREK RX CORONARY DILATATION CATHETER AND NC TRAVELER CORONARY DILATATION CATHETER. THE FIELD SAFETY ACTION NUMBER IS 2024168-1/27/2020-001. THIS ACTION IS BEING TAKEN AS A RESULT OF AN INCREASE IN THE COMPLAINT TREND FOR REPORTED FAILURES OF DEFLATION FOR NC TREK RX AND NC TRAVELER RX CORONARY DILATATION CATHETER. PRODUCT FROM IDENTIFIED LOTS MAY EXHIBIT SLOW, PARTIAL OR FAILURE TO DEFLATE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED ONE MANUFACTURING NONCONFORMITY ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED ONE SIMILAR COMPLAINT FROM THIS LOT WHICH IS ASSOCIATED WITH AN EXCEPTION. THE INVESTIGATION DETERMINED THE REPORTED DEFLATION ISSUE IS RELATED TO A MANUFACTURING ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED. ADDITIONALLY, IT IS MOST LIKELY THAT THE REPORTED DEFLATION ISSUE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS OF PERFORATION, OCCLUSION AND DEATH. ON (B)(6)2020 , THE ABBOTT VASCULAR DETERMINED THAT A FIELD SAFETY CORRECTIVE ACTION IS REQUIRED FOR SPECIFIC LOTS OF NC TREK RX CORONARY DILATATION CATHETER AND NC TRAVELER CORONARY DILATATION CATHETER. THE FIELD SAFETY ACTION NUMBER IS 2024168-1/27/2020-001. THIS ACTION IS BEING TAKEN AS A RESULT OF AN INCREASE IN THE COMPLAINT TREND FOR REPORTED FAILURES OF DEFLATION FOR NC TREK RX AND NC TRAVELER RX CORONARY DILATATION CATHETER. PRODUCT FROM IDENTIFIED LOTS MAY EXHIBIT SLOW, PARTIAL OR FAILURE TO DEFLATE.H10

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ON JANUARY 15, 2020, THE ABBOTT VASCULAR DETERMINED THAT A FIELD SAFETY CORRECTIVE ACTION IS REQUIRED FOR SPECIFIC LOTS OF NC TREK RX CORONARY DILATATION CATHETER AND NC TRAVELER CORONARY DILATATION CATHETER. THE FIELD SAFETY ACTION NUMBER IS 2024168-1/27/2020-001. THIS ACTION IS BEING TAKEN AS A RESULT OF AN INCREASE IN THE COMPLAINT TREND FOR REPORTED FAILURES OF DEFLATION FOR NC TREK RX AND NC TRAVELER RX CORONARY DILATATION CATHETER. PRODUCT FROM IDENTIFIED LOTS MAY EXHIBIT SLOW, PARTIAL OR FAILURE TO DEFLATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION. A PERCUTANEOUS CORONARY INTERVENTION WAS INITIATED ON THE LEFT ANTERIOR DESCENDING (LAD), MODERATELY CALCIFIED LESION. AN NC TREK (1012453-20, 90923G1) DILATATION CATHETER ADVANCED TO THE LESION SITE AND INFLATED WITHOUT REPORTED ISSUES. DEFLATION WAS ATTEMPTED; HOWEVER, THE BALLOON WAS UNABLE TO DEFLATE. AS TROUBLESHOOTING, THE BALLOON WAS RE-INFLATED. THE BALLOON HAD THEN RUPTURED AND THE LAD PERFORATED. A COVERED STENT WAS IMPLANTED AS TREATMENT. THE DIAGONAL CORONARY ARTERY THEN ¿SHUT DOWN¿. PERICARDIOCENTESIS WAS PERFORMED. ON (B)(6) 2020, THE PATIENT HAD EXPIRED WHILE IN CRITICAL CARE. NO ADDITIONAL INFORMATION AS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189843 NC TREK RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012453-20 90923G1 08717648152085

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death