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

Model Number	01-0011-001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon was inserted on (b)(6) 2018.During the scheduled routine removal on (b)(6) 2018, the physician found the distal balloon deflated upon insertion of the scope.The patient reported no blue/green urine or any other type of symptoms prior to the removal.
Event or Problem Description
The balloon was inserted on (b)(6) 2018.During the scheduled routine removal on (b)(6) 2018, the physician found the distal balloon deflated upon insertion of the scope.The patient reported no blue/green urine or any other type of symptoms prior to the removal.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Common Device Name: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• MDR Report Key: 7951485
• Report Number: 3007934906-2018-00033
• Device Sequence Number: 16540399
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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 Expiration Date: 08/31/2019
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 180102-002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR