BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 6748351 · Received July 27, 2017

    Report

    Report Number
    2248146-2017-00187
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    July 7, 2017
    Report Date
    September 7, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    08/18/2017 (B)(4): 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. COMPLAINT # (B)(4), RECORD # 142979.

    Additional Manufacturer Narrative · 1

    09/07/2017 (B)(4): THE IAB WAS RETURNED WITH THE MEMBRANE COMPLETELY AND THE STYLET WIRE IN PLACE. NO BLOOD WAS OBSERVED ON THE IAB. THE STYLET WAS REMOVED FROM THE IAB AND FOUND TO BE BENT IN TWO PLACES NEAR THE MIDDLE. THREE KINKS WERE FOUND ON THE CATHETER TUBING APPROXIMATELY 37.6CM, 51.3CM AND 51.6CM FROM THE IAB TIP. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE IAB WAS PLACED ON THE CS300 PUMP AND PUMPED FOR TWO HOURS WHICH REPRESENTS ONE COMPLETE AUTO FILL CYCLE. THE IAB PUMPED NORMALLY AND NO ALARM SOUNDED FROM THE PUMP. WE WERE UNABLE TO DUPLICATE THE REPORTED PROBLEMS. IT IS DIFFICULT TO DETERMINE WHEN OR HOW A KINK IN THE CATHETER OCCURS. ALTHOUGH WE DID NOT REPEAT THIS EVENT IN THE LABORATORY SETTING, A KINK IN THE CATHETER CAN CAUSE INFLATION DIFFICULTY OR AN ALARM. 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); RECORD # (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. WE CONTINUE OUR EFFORTS TO FOLLOW UP WITH THE CUSTOMER FOR ITS RETURN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, DURING CARDIOGENIC SHOCK, UNDERWENT INTRA-AORTIC BALLOON (IAB) CATHETER THERAPY. AFTER THE IAB WAS INSERTED IT WAS DETERMINED THE AUGMENTATION WAS INADEQUATE. UNDER FLUOROSCOPY IT WAS DETERMINED THAT THE UPPER PART OF THE BALLOON WAS NOT EXPANDING PROPERLY AFTER 15 MINUTES. THE IAB WAS REPLACED WITH A NEW IAB. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, DURING CARDIOGENIC SHOCK, UNDERWENT INTRA-AORTIC BALLOON (IAB) CATHETER THERAPY. AFTER THE IAB WAS INSERTED IT WAS DETERMINED THE AUGMENTATION WAS INADEQUATE. UNDER FLUOROSCOPY IT WAS DETERMINED THAT THE UPPER PART OF THE BALLOON WAS NOT EXPANDING PROPERLY AFTER 15 MINUTES. THE IAB WAS REPLACED WITH A NEW IAB. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, DURING CARDIOGENIC SHOCK, UNDERWENT INTRA-AORTIC BALLOON (IAB) CATHETER THERAPY. AFTER THE IAB WAS INSERTED IT WAS DETERMINED THE AUGMENTATION WAS INADEQUATE. UNDER FLUOROSCOPY IT WAS DETERMINED THAT THE UPPER PART OF THE BALLOON WAS NOT EXPANDING PROPERLY AFTER 15 MINUTES. THE IAB WAS REPLACED WITH A NEW IAB. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528035 LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000029032

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR