MAUDE Adverse Event Report: RESHAPE MEDICAL RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number	01-0011-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloons were inserted on (b)(6) 2018.The next day, the patient reported a temperature of 101, chest pain and vomiting.A chest and abdominal ct scans with oral contrast were performed.The ct chest was normal, the ct abdominal showed the balloon in place, distended gastric fundus, and retained gastric contents surrounding the balloon.The device was removed on (b)(6) 2018.Additional information received on april 24, 2018 confirmed there was a gastric outlet obstruction.The patient was reported to be doing fine following the device removal.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Common Device Name: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL; 100 calle iglesia; san clemente CA 92672 7502
• MDR Report Key: 7557233
• Report Number: 3007934906-2018-00022
• Device Sequence Number: 13908009
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/16/2019
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 171018-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR