BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENT - BALLOON CATHETER

    MDR report key: 4339686 · Received December 18, 2014

    Report

    Report Number
    3004107186-2014-10002
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    December 5, 2014
    Report Date
    February 3, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    MJN
    PMA / PMN Number
    K080861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURN FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.(B)(4).

    Additional Manufacturer Narrative · 1

    THE LABELING GUIDELINES WERE USED TO PREP THE BALLOON, AND NO EXCESSIVE FORCE WAS USED OR TO PREP THE BALLOON. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN OPENED FIRST ASCENT DURING PROCEDURE AND PREPPED FOR USE IAW THE IFU. WHILE ATTEMPTING TO PUSH CONTRAST OUT THE VENT HOLE, PHYSICIAN NOTED THAT THE BALLOON POPPED BEFORE CONTRAST BEADED OUT FROM THE TOP OF THE UNIT. HE NOTED THAT HE HAD .014 WIRE IN PLACE DURING THE ATTEMPTED PREPARATION, IAW THE IFU. THE PHYSICIAN SWAPPED OUT THE BALLOON FOR ANOTHER 6X9 ASCENT BALLOON AND PREPPED IT WITHOUT INCIDENT. THE STAFF DISCARDED THE FIRST BALLOON SO IT IS UNAVAILABLE FOR EVALUATION. NO PATIENT INJURY RESULTED. THE PHYSICIAN NOTED THAT NO KINKING OR DAMAGE WAS EVIDENT ON THE FIRST BALLOON. CONTRAST RATIO 50/50. PROCEDURE WAS ¿SPINAL ANGIO AND EMBO.¿ THE LABELING GUIDELINES WERE USED TO PREP THE BALLOON, AND NO EXCESSIVE FORCE WAS USED OR TO PREP THE BALLOON. THE ASCENT BALLOON WAS NOT RETURNED; THEREFORE, THE ROOT CAUSE OF THE EVENT COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND THE EVENT CANNOT BE CONFIRMED. WITH THE INFORMATION PROVIDED IT IS POSSIBLE THAT PROCEDURE FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKING AT THIS TIME.

    Description of Event or Problem · 1

    PHYSICIAN OPENED FIRST ASCENT DURING PROCEDURE AND PREPPED FOR USE IAW THE IFU. WHILE ATTEMPTING TO PUSH CONTRAST OUT THE VENT HOLE, PHYSICIAN NOTED THAT THE BALLOON POPPED BEFORE CONTRAST BEADED OUT FROM THE TOP OF THE UNIT. HE NOTED THAT HE HAD .014 WIRE IN PLACE DURING THE ATTEMPTED PREPARATION, IAW THE IFU. THE PHYSICIAN SWAPPED OUT THE BALLOON FOR ANOTHER 6X9 ASCENT BALLOON AND PREPPED IT WITHOUT INCIDENT. THE STAFF DISCARDED THE FIRST BALLOON SO IT IS UNAVAILABLE FOR EVALUATION. REQUEST OVERNIGHT REPLACEMENT OF DEFECTIVE FIRST UNIT. NO PATIENT INJURY RESULTED. THE PHYSICIAN NOTED THAT NO KINKING OR DAMAGE WAS EVIDENT ON THE FIRST BALLOON. CONTRAST RATIO 50/50. PROCEDURE WAS ¿SPINAL ANGIO AND EMBO.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831672 ASCENT - BALLOON CATHETER CES BALLOON CATHETER MJN CODMAN AND SHURTLEFF, INC F73486

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR