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 Problem Pulmonary Embolism (1498)

Event Date 10/30/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, patient contacted implanting md and complained of weakness and retching, but denied vomiting.Patient denied green/blue urine.On (b)(6) 2016, patient reported having difficulty with solid foods, but was able to tolerate protein shakes and yogurt.Patient also stated that she had no voice since the procedure.Patient was advised to stay on liquids over the weekend and visit md's office for follow up the next week.The patient was advised that if she began vomiting to call md's office and go to er.On (b)(6) 2016, md was able to speak directly with patient.Per md, she was very weak and had difficulty ambulating and shortness of breath.Md advised her to call 911 and go to er for evaluation.On (b)(6) 2016, patient went to er.Patient was diagnosed as having a bilateral pulmonary embolism and was anticoagulated with heparin.On (b)(6) 2016, patient was reported stable and placed on heparin drip, and that patient would be advancing to oral anti-coagulation the next day.On (b)(6) 2016, patient had balloon removed by implanting physician.Balloon was removed on (b)(6) 2016 and no further sequelae were reported.

• 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: 6274073
• MDR Text Key: 65626205
• Report Number: 3007934906-2017-00002
• 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: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/26/2017
• Device Model Number: 01-0011-001
• Device Catalogue Number: RSM101
• Device Lot Number: 160714-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2016
• 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; Other
• Patient Age: 67 YR