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

Model Number RSM101

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

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Ulceration (2116)

Event Date 04/16/2016

Event Type  Injury  

Event Description

Patient presented to (b)(6) er on (b)(6) 20116 with dark stool and fatigue.Hemoglobin level of 5.8 attributed to large gi bleed.Patient was admitted to hospital.Admission records indicate patient was not taking ppis.Troponin levels were elevated, indicating a myocardial infarction.Cardiac catheterization showed 2 vessel coronary disease and need for cardiac bypass surgery.Patient given option to have balloon removed prior to or after cardiac bypass surgery.Balloon was successfully removed endoscopically on (b)(6) 2016.Both balloons were fully intact with appropriate positioning in the stomach.One 5mm ulcer was noted in the mid-body of the stomach.This ulcer was non-bleeding with no visible vessels.Food content of stomach hampered visual inspection of the gastric fundus.

• 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: 5651890
• MDR Text Key: 45092358
• Report Number: 3007934906-2016-00010
• 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: 06/01/2016

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: Physician
• Device Expiration Date: 02/28/2017
• Device Model Number: RSM101
• Device Catalogue Number: 01-0011-001
• Device Lot Number: 160308-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/01/2016; 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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
• Patient Age: 50 YR
• Patient Weight: 113