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

Model Number 01-0011-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 09/12/2018

Event Type  Injury  

Event Description

A patient with the reshape dual balloon system had complaints of intense pain radiating to their back.The patient's lab results noted a lipase of 26,000.The patient was flown emergently to a hospital for removal of the device due to pancreatitis.The patient was discharged after the normalization of their lipase and resolution of the abdominal pain.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. capital of texas hwy; austin TX 78746
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; austin, TX 78746
• MDR Report Key: 8601765
• MDR Text Key: 144797297
• Report Number: 3006722112-2019-00501
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization