BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 6793155 · Received August 14, 2017

    Report

    Report Number
    2248146-2017-00297
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 18, 2017
    Report Date
    August 31, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    08/31/2017 (B)(4): THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER AND BLOOD WITHIN INNER LUMEN, AND MEMBRANE. THE RETURNED SHEATH WAS OVER THE CATHETER WITH THE TIP OF THE SHEATH CUT. A VISUAL EXAMINATION OF THE PRODUCT DETECTED THE INNER LUMEN WITHIN THE CATHETER TUBING WAS COMPLETELY SEPARATED WITHIN A KINK LOCATED 28.5CM FROM IAB TIP. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING, EXTRACORPOREAL TUBING AND EXTENSION TUBING WAS PERFORMED AND NO OTHER LEAKS WERE DETECTED. THE EVALUATION CONFIRMED THE REPORTED PROBLEM. 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 CATHETER TUBING AND MEMBRANE 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. 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 #: CA-CPL-2017-01912 ; RECORD ID: 143608 SUPPLEMENT - DEVICE EVALUATION

    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 DURING INTRA-AORTIC BALLOON (IAB) CATHETER THERAPY THAT BLOOD WAS SEEN IN THE TUBING 5 MINUTES AFTER INSERTION. IT WAS FOUND THAT THE BOTTOM OF THE LUMEN WAS FRACTURED AFTER IAB REMOVAL. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) CATHETER THERAPY THAT BLOOD WAS SEEN IN THE TUBING 5 MINUTES AFTER INSERTION. IT WAS FOUND THAT THE BOTTOM OF THE LUMEN WAS FRACTURED AFTER IAB REMOVAL. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571414 LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000047421

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR