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

Model Number 01-0011-001

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

Patient Problem Perforation (2001)

Event Date 02/17/2018

Event Type  Injury  

Manufacturer Narrative

The device is currently under investigation.Once the investigation is completed, a follow up report will be submitted with the results from the investigation.

Event Description

The patient had the balloons inserted on (b)(6) 2018.Four days' post-op, the patient presented to emergency room with acute abdominal pain.A ct scan showed a small stomach perforation on the anterior portion of the patient's stomach.The patient was admitted to the hospital on the same day.The perforation was successfully repaired and patient was discharged from the hospital on (b)(6) 2018.

Event Description

The patient had the balloons inserted on (b)(6) 2018.Four days' post-op, the patient presented to emergency room with acute abdominal pain.A ct scan showed a small stomach perforation on the anterior portion of the patient's stomach.The patient was admitted to the hospital on the same day.The perforation was successfully repaired and patient was discharged from the hospital on (b)(6) 2018.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): RESHAPE MEDICAL; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer (Section G): RESHAPE MEDICAL; 100 calle iglesia; san clemente CA 92672 7502
• Manufacturer Contact: kristin wielenga ; 100 calle iglesia; san clemente, CA 92672-7502 ; 9492188639
• MDR Report Key: 7362741
• MDR Text Key: 103208471
• Report Number: 3007934906-2018-00012
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 24 YR