BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RCSP RETROGRADE CANNULA

    MDR report key: 3467981 · Received November 13, 2013

    Report

    Report Number
    2184009-2013-00064
    Event Type
    Injury
    Date Received
    November 13, 2013
    Date of Event
    October 4, 2013
    Report Date
    October 15, 2013
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K901074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED, AND NO SIMILAR EVENTS WERE FOUND. INFORMATION RECEIVED FROM THE USER INDICATED THAT THE PRODUCT WAS NOT USED AS DESIGNED. THE USER MENTIONED HE HAD CHANGED THE SYRINGE USED TO INFLATE THE BALLOON. THE DIFFERENCE IN SIZE OF SYRINGE POTENTIALLY CAUSED THE BALLOON TO OVER-INFLATE AND RUPTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT FILED TO ADD 510(K) APPROVAL NUMBER: K901074.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT WHILE THIS RETROGRADE CANNULA WAS BEING USED IN A PROCEDURE, THE CORONARY SINUS WAS RIPPED. THE DOCTOR SUTURED THE DAMAGED AREA AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE DOCTOR BELIEVED THAT HE HAD OVER-INFLATED THE BALLOON, AND STATED THAT HE HAD NOT BEEN USING THE SYRINGE THAT IS PACKAGED WITH THE CANNULA. PRODUCT RETURN IS NOT EXPECTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT WHILE THIS RETROGRADE CANNULA WAS BEING USED IN A PROCEDURE, THE CORONARY SINUS WAS RIPPED. THE DOCTOR SUTURED THE DAMAGED AREA AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE DOCTOR BELIEVED THAT HE HAD OVER-INFLATED THE BALLOON, AND STATED THAT HE HAD NOT BEEN USING THE SYRINGE THAT IS PACKAGED WITH THE CANNULA. PRODUCT RETURN IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586982 RCSP RETROGRADE CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MEDTRONIC PERFUSION SYSTEMS 94965 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention