MAUDE Adverse Event Report: RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON; INTRAGASTRIC BALLOON

Model Number 01-0011-001

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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).

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL, INC.; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer (Section G): RESHAPE MEDICAL, INC.; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: greg geissinger ; 100 calle iglesia; san clemente, CA 92672-7502
• MDR Report Key: 6487551
• MDR Text Key: 72668455
• Report Number: 3007934906-2017-00010
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/26/2016
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 151005-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other