MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number	01-0011-001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had the reshape dual balloon successfully implanted approximately two (2) months ago.In the last few weeks, the patient noted discolored urine and decrease in satiety.The patient is scheduled for an egd to determine if the balloon(s) are leaking.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Common Device Name: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. capital of texas hwy; building 1, suite 300; austin TX 78746
• MDR Report Key: 8636698
• Report Number: 3006722112-2019-00502
• Device Sequence Number: 19297352
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1