BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 8FR. 50CC IAB

    MDR report key: 7022871 · Received November 10, 2017

    Report

    Report Number
    2248146-2017-00631
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 10, 2017
    Report Date
    January 12, 2018
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K112327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    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. COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE LOOSELY FOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. THE GUIDE WIRE WAS ALSO RETURNED. NO DAMAGE WAS OBSERVED ON THE GUIDE WIRE. ONE KINK WAS FOUND ON THE CATHETER TUBING NEAR THE Y-FITTING APPROXIMATELY 76.2CM FROM THE IAB TIP. THE OPTICAL FIBER WAS FOUND TO BE BROKEN AT THIS LOCATION. THE TECHNICIAN ATTEMPTED TO INSERT THE RETURNED 0.025¿ GUIDE WIRE THROUGH THE INNER LUMEN OF THE RETURNED IAB AND FOUND THAT THE INNER LUMEN WAS OCCLUDED. THE TECHNICIAN WAS UNABLE TO CLEAR THE OCCLUSION, HOWEVER EVIDENCE OF DRIED BLOOD WAS OBSERVED AT THE TIP OF THE GUIDE WIRE. THERE WAS NO EVIDENCE OF THE GUIDE WIRE BROKEN OFF INSIDE IAB CATHETER. THE CONDITION OF THE IAB AS RECEIVED INDICATED DRIED BLOOD OCCLUDING THE INNER LUMEN. THE REPORTED GUIDE WIRE BROKE INSIDE THE BALLOON CANNOT BE CONFIRMED BY THE EVALUATION. 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).

    Additional Manufacturer Narrative · 1

    COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY THE GUIDE WIRE BROKE INSIDE THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY THE GUIDE WIRE BROKE INSIDE THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE INDICATION FOR THE PROCEDURE WAS A LHL WITH CORONARY ANGIOGRAM. IAB PLACEMENT FOR CABG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY THE GUIDE WIRE BROKE INSIDE THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE INDICATION FOR THE PROCEDURE WAS A LHL WITH CORONARY ANGIOGRAM. IAB PLACEMENT FOR CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802511 SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000054904

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR