MAUDE Adverse Event Report: RESHAPE MEDICAL 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 Pulmonary Embolism (1498); Death (1802); Perforation (2001); Thrombus (2101)

Event Date 08/14/2017

Event Type  Death  

Event Description

Patient reported onset of back pain 3.5 weeks following balloon insertion.On (b)(6) 2017 md performed endoscopy, noted presence of significant amount of food in the stomach, removed the balloons and noted a distal gastric perforation.Perforation was surgically repaired and patient remained hospitalized for approximately 2 weeks for post-op management and treatment.On day of death (while still hospitalized), patient was ambulatory, non-febrile, with normal heart rate and white blood count but then experienced sudden heart rate drop and, despite immediate medical intervention efforts, expired on (b)(6) 2017.Icu md said cause of death was a pulmonary embolism by clinical presentation and no autopsy was done.

Manufacturer Narrative

Follow up #2 to correct patient code which was incorrectly coded as (b)(4) in follow up #1 and to add additional event information.

Event Description

Follow up: per the physician, one week after the balloon removal and perforation repair, the patient had a sudden onset of pain while still hospitalized and the white blood cell count was elevated.The patient was transferred to another hospital to obtain a cat scan and another gastric leak was found.The patient was taken to the or.It was determined the original repair was unsuccessful.The area was cleaned out, re-repaired and drained again.The patient continued to improve daily with a normal white cell count, afebrile, stable vitals and tolerating liquids.On day 7 following the second surgery, the patient had a sudden event and was transferred to icu where two hours of resusitation were unsuccessful.

• 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: lisa maloney ; 100 calle iglesia; san clemente, CA 92672-7502 ; 9494296680
• MDR Report Key: 6967005
• MDR Text Key: 89912797
• Report Number: 3007934906-2017-00032
• 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,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/09/2019
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 170515-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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; Hospitalization
• Patient Age: 53 YR