BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5 FR. 40CC

    MDR report key: 9749614 · Received February 25, 2020

    Report

    Report Number
    2248146-2020-00114
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 16, 2020
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED. BLOOD WAS LOCATED ON THE INTERIOR AND EXTERIOR OF THE CATHETER WITH TRACES OF BLOOD IN THE MEMBRANE. THE EXTENDER TUBING AND THREE-WAY STOP COCK WERE ALSO RETURNED. A KINK WAS FOUND ON THE CATHETER TUBING NEAR THE Y-FITTING APPROXIMATELY 75.7 CM FROM THE IAB TIP. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, INNER LUMEN, Y-FITTING, EXTRACORPOREAL AND EXTENDER TUBING WAS PERFORMED AND ONE LEAK WAS FOUND ON THE CATHETER TUBING NEAR THE Y-FITTING APPROXIMATELY 55.9 CM FROM THE IAB TIP. THE LEAK SITE WAS OBSERVED TO BE 0.44 CM IN LENGTH. THE TECHNICIAN ATTEMPTED TO INSERT LABORATORY GUIDEWIRE (0.018¿) THROUGH THE INNER LUMEN OF THE RETURNED IAB AND FOUND THAT THE INNER LUMEN WAS OCCLUDED. THE TECHNICIAN WAS UNABLE TO CLEAR THE OCCLUSION AND EVIDENCE OF DRIED BLOOD WAS OBSERVED AT THE TIP OF THE GUIDE WIRE. THE PENETRATION FOUND IN THE CATHETER TUBING APPEARS TO HAVE BEEN CAUSED BY A SHARP OBJECT. THOUGH WE ARE UNABLE TO DETERMINE WHEN THE PENETRATION MAY HAVE OCCURRED, IT IS LIKELY THAT IT CAUSED THE REPORTED PROBLEM. A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. PER COMPLAINT HANDLING PROCEDURE, 01-061, THIS COMPLAINT DID NOT MEET THE REQUIREMENTS FOR ESCALATION TO HHE OR CRF. JS (B)(6) 2020. COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON(IAB) THERAPY, BLOOD WAS SEEN IN THE TUBING. THE BALLOON CATHETER WAS REMOVED AND TREATMENT WAS CONTINUED WITH ANOTHER INTRA-AORTIC BALLOON(IAB). THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 RECORD ID # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON(IAB) THERAPY, BLOOD WAS SEEN IN THE TUBING. THE BALLOON CATHETER WAS REMOVED AND TREATMENT WAS CONTINUED WITH ANOTHER INTRA-AORTIC BALLOON(IAB). THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214585 TRANS-RAY PLUS 7.5 FR. 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000096708

    Patients

    Seq Age Sex Outcome Treatment
    1