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

Model Number 01-0011-001

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

Patient Problems Death (1802); Sepsis (2067); Perforation of Esophagus (2399)

Event Date 03/20/2016

Event Type  Death  

Manufacturer Narrative

There is no known allegation from a health professional that the patient death was related to the device.

Event Description

Patient underwent an uneventful balloon insertion on 2/16/16.Patient experienced vomiting and pain and presented at er on (b)(6) 2016; diagnostic evaluation noted presence of kidney stone.Subsequent treatment during er visit, if any, was not reported.Patient presented at implanting surgeon's er on (b)(6) 2016 with severe chest pain.Diagnosed as distal, 1 cm esophageal perforation and leak.Stent placed endoscopically over perforation followed by same day laparoscopic removal of balloon and repair of perforation.Physician noted normal balloon appearance and position.Patient remained hospitalized with sepsis and expired (b)(6) 2016.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON
• 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: 5582765
• MDR Text Key: 42848134
• Report Number: 3007934906-2016-00006
• 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
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• 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): Death
• Patient Age: 52 YR
• Patient Weight: 91