BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC UNKNOWN

    MDR report key: 5090834 · Received September 21, 2015

    Report

    Report Number
    3010532612-2015-00020
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYG
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: NO PRODUCT WAS RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF INTERLUMEN CROSSOVER IS NOT ABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A (B)(6) BABY. THE BERMAN ANGIOGRAPHY WAS DONE AND WHEN INJECTING CONTRAST, THE CONTRAST WAS REPORTED TO HAVE BEEN EXPELLED OUT OF THE TIP OF THE CATHETER, AND NOT THE DISTRIBUTION PORTS. THE CONTRAST BEGAN TO FILL THE BALLOON ITSELF. THE CLINICAL SUPPORT SPECIALIST ASKED IF THEY WERE SURE THAT THE CONTRAST WAS DELIVERED INTO THE INJECTION PORT AND NOT THE BALLOON PORT AND THE CLINICIAN STATED THAT IT WAS NOT INJECTED INTO THE BALLOON PORT. THE PHYSICIAN HAD CONCERNS ABOUT DEFLATING THE BALLOON WITH CONTRAST IN IT, BUT WOULD NEED TO DEFLATE THE BALLOON FOR REMOVAL. THE RN STATED THAT THE MD LET THE BALLOON DEFLATE SLOWLY AND WAS ABLE TO GET IT DEFLATED AND REMOVED WITHOUT INCIDENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS, INJURY OR DEATH. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A (B)(6). THE BERMAN ANGIOGRAPHY WAS DONE AND WHEN INJECTING CONTRAST, THE CONTRAST WAS REPORTED TO HAVE BEEN EXPELLED OUT OF THE TIP OF THE CATHETER, AND NOT THE DISTRIBUTION PORTS. THE CONTRAST BEGAN TO FILL THE BALLOON ITSELF. THE CLINICAL SUPPORT SPECIALIST ASKED IF THEY WERE SURE THAT THE CONTRAST WAS DELIVERED INTO THE INJECTION PORT AND NOT THE BALLOON PORT AND THE CLINICIAN STATED THAT IT WAS NOT INJECTED INTO THE BALLOON PORT. THE PHYSICIAN HAD CONCERNS ABOUT DEFLATING THE BALLOON WITH CONTRAST IN IT, BUT WOULD NEED TO DEFLATE THE BALLOON FOR REMOVAL. THE RN STATED THAT THE MD LET THE BALLOON DEFLATE SLOWLY AND WAS ABLE TO GET IT DEFLATED AND REMOVED WITHOUT INCIDENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS, INJURY OR DEATH. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623035 CARDIAC UNKNOWN BERNAN ANGIOGRAPHIC CATHETER PRODUCT DYG ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA