BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 6487551 · Received April 12, 2017

    Report

    Report Number
    3007934906-2017-00010
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    May 24, 2016
    Report Date
    April 10, 2017
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH MDR #3007934906-2017-00010 WAS DISPOSED OF IMMEDIATELY FOLLOWING THE REMOVAL PROCEDURE IN ACCORDANCE WITH THE MEDICAL CENTER'S NORMAL PRACTICES. RESHAPE MEDICAL ENCOURAGES ALL CUSTOMERS TO RETURN ANY DEVICES ASSOCIATED WITH COMPLAINTS SO THAT THE COMPANY CAN COMPLETE A FULL INVESTIGATION. HOWEVER, IN THIS CASE THE TREATING PHYSICIAN DID NOT MAKE THE DEVICE AVAILABLE FOR EVALUATION. THE IMPLANT CONSISTS OF A SILICONE BALLOON SHELL TETHERED TO A CENTRAL SHAFT. THE TYPICAL SILICONE BALLOON FILL VOLUME IS 450CC. IN THIS CASE, THE DISTAL SILICONE BALLOON SHELL APPEARED INFLATED MORE THAN 450CC AT THE TIME OF BALLOON REMOVAL. THE EXACT FILL VOLUME AND DIMENSIONS AT THE TIME OF BALLOON REMOVAL IS UNKNOWN. THERE HAVE BEEN NO DESIGN CHANGES TO THE DEVICE SINCE IT WAS INITIALLY INTRODUCED TO THE MARKET, AND RESHAPE HAS IDENTIFIED NO STEPS IN THE MANUFACTURING PROCESS THAT COULD CONTRIBUTE TO THE REPORTED PROBLEM. RESHAPE HAS NOT RECEIVED ANY ADDITIONAL EVALUATION OF THE EVENT FROM THE TREATING PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL. THIS IS RESHAPE'S ONLY REPORTED COMMERCIAL INCIDENT OF A DEVICE OVER-INFLATION.

    Description of Event or Problem · 1

    FOLLOWING BALLOON INSERTION ON (B)(6) 2015, PATIENT REPORTED SYMPTOMS OF NAUSEA AND VOMITING THAT PERSISTED THROUGHOUT THE 6-MONTH BALLOON IMPLANT PERIOD. AT SCHEDULED 6-MONTH ENDOSCOPIC BALLOON REMOVAL, MD REPORTED OBSERVING GAS IN THE DISTAL BALLOON ASSOCIATED WITH BALLOON OVER-INFLATION. STOMACH FINDINGS WERE NORMAL AND PATIENT HAD NO SEQUELAE POST-BALLOON REMOVAL. MD NOTED THAT PATIENT HAD POOR FOLLOW UP COMPLIANCE, BUT VERY SUCCESSFUL WEIGHT LOSS (LOST 63 LBS AND WEIGHED (B)(6) AT BALLOON REMOVAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270525 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 151005-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other