BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS RX LIFESTREAM CORONARY DILATATION CATHETER

    MDR report key: 76589 · Received March 14, 1997

    Report

    Report Number
    2024168-1997-00044
    Event Type
    Malfunction
    Date Received
    March 14, 1997
    Date of Event
    January 17, 1997
    Report Date
    March 14, 1997
    Manufacturer
    ACS/DVI
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF OUR ANALYSIS CONCLUDED THAT TWO COMPONENTS (THE HYPOTUBE JACKET AND ADAPTION CUP) WERE NOT SUFFICIENTLY BONDED TOGETHER. THIS INCOMPLETE BOND WAS RELATED TO THE HEAT INDUCTION PROCESS USED TO COMPLETE THE BOND IN THIS LOCATION. PREVIOUS TO THIS INCIDENT A FILING WAS SUBMITTED TO THE FDA AND APPROVED (12/28/95) WHICH ADDRESSES THIS ISSUE (PMA#P810046/S160). THESE CHANGES HAVE BEEN IMPLEMENTED BY MFG, NO OTHER REMEDIAL ACTION HAS BEEN TAKEN. SINCE THE BEGINNING OF 1996 UNITS HAVE BEEN SHIPPED WITH THIS PROCESS IMPROVEMENT. THE DEVICE IN QUESTION WAS MADE PREVIOUS TO THESE CHANGES. A REVIEW OF THE COMPLAINT TREND DATA FOR THIS TYPE OF COMPLAINT SHOWED THAT ITS SEVERITY IS EXTREMELY LOW. IT IS VERY UNLIKELY THAT A HUB SEPARATION COULD CAUSE OR CONTRIBUTE TO A SERIOUS PATIENT OUTCOME, ESPECIALLY IN A RAIL (RX) DEVICE. QUALITY ASSURANCE CONTINUES TO MONITOR THE DEVICE FOR THIS TYPE OF COMPLAINT. THE COMPLAINT RATE HAS SIGNIFICANTLY DECREASED SINCE THE PROCESS MODIFICATION WAS IMPLEMENTED. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUB SEPARATED FROM THE CATHETER DURING PREP. REPORTEDLY, NO PT INJURY WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX LIFESTREAM CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ACS/DVI NA 51121252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other