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

Model Number RSM101

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

Patient Problems Perforation (2001); Obstruction/Occlusion (2422)

Event Date 03/30/2016

Event Type  Injury  

Event Description

Patient presented with abdominal pain on (b)(6) 2016.Ugi revealed a gastric outlet obstruction attributable to the inflated device.The balloon was removed endoscopically and a gastric perforation was created incidental to the removal procedure.Patient underwent surgical repair (laparotomy) of the perforation and was released from the hospital on (b)(6) 2016.No further sequelae were reported.

Manufacturer Narrative

Fda misinterpreted the original event description as involving a device over-inflation.This narrative clarifies that the event description did not describe over-inflation in any way.The health professional's reference to the "inflated device" was only intended to describe the normal, fluid-filled balloon implant.There is no report that the device malfunctioned.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• 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 ; 9494296680
• MDR Report Key: 5598735
• MDR Text Key: 43348610
• Report Number: 3007934906-2016-00008
• 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,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/16/2016
• Device Model Number: RSM101
• Device Catalogue Number: 01-0011-001
• Device Lot Number: 160119-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 91