BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION 7FR. 40CC IAB

    MDR report key: 7264659 · Received February 12, 2018

    Report

    Report Number
    2248146-2018-00091
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Report Date
    March 22, 2018
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D.1. CHANGED FROM: SENSATION PLUS 7.5FR. 40CC IAB TO: SENSATION 7FR. 40CC IAB D.4. CATALOG # CHANGED FROM: 0684-00-0567 TO: 0684-00-0434 SECTION G.5. WAS BLANK IN PREVIOUS SUBMISSION, BUT SHOULD HAVE BEEN POPULATED. CORRECT 510K # ADDED. ADDITIONAL INFORMATION: FACILITY SUBMITTED MEDWATCH (B)(4) RECEIVED BY THE MANUFACTURER ON 05MARCH2018 INDICATING PRODUCT WAS A SENSATION PLUS 7.5FR. 40CC IAB HOWEVER PRODUCT RECEIVED BY THE MANUFACTURER WAS A SENSATION 7FR. 40CC IAB. DEVICE EVALUATION: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. THE EXTENDER TUBING WAS ALSO RETURNED. A VISUAL EXAMINATION OF THE PRODUCT DETECTED THE INNER LUMEN WITHIN THE MEMBRANE WAS COMPLETELY SEPARATED WITHIN A KINK APPROXIMATELY 26.4CM FROM IAB TIP. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING, EXTRACORPOREAL AND EXTENDER TUBING WAS PERFORMED AND NO OTHER LEAKS WERE DETECTED. THE BREAK FOUND IN THE INNER LUMEN APPEARS TO HAVE BEEN THE RESULT OF A SEVERE KINK, WHICH EVENTUALLY FAILED AND ALLOWED BLOOD TO LEAK INTO THE MEMBRANE AND CATHETER TUBING CAUSING THE REPORTED PROBLEMS. IT IS DIFFICULT TO DETERMINE WHEN THE BREAK OCCURRED BUT IT IS POSSIBLY A RESULT OF PATIENT MOVEMENT DURING THE PROCEDURE. THE EVALUATION CONFIRMED THE REPORTED PROBLEM. A SEVERE KINK OR CONTINUOUS FLEXING OF A KINK CAN CAUSE THE INNER LUMEN TO BREAK RESULTING IN A LEAK. A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRA-AORTIC BALLOON (IAB) HAD A "PRODUCT FAILURE". IT WAS LATER CLARIFIED BY THE CUSTOMER THAT THE IAB TUBING HAD BLOOD, AS IF IT HAD RUPTURED. THE PHYSICIAN EXAMINED THE IAB, BUT COULD NOT FIND A HOLE. THE IAB THEN HAD TO BE REMOVED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE EVENT DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRA-AORTIC BALLOON (IAB) HAD A "PRODUCT FAILURE". IT WAS LATER CLARIFIED BY THE CUSTOMER THAT THE IAB TUBING HAD BLOOD, AS IF IT HAD RUPTURED. THE PHYSICIAN EXAMINED THE IAB, BUT COULD NOT FIND A HOLE. THE IAB THEN HAD TO BE REMOVED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE EVENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106021 SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000011692

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR