MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. RESHAPE INTEGRATED DUAL BALLOON SYSTEM; INTRAGASTRIC BALLOON

Model Number RSM101

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

Patient Problems Pain (1994); Sepsis (2067); Patient Problem/Medical Problem (2688)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to the fda.A review of the device labeling notes the following: the current reshape¿ integrated dual balloon system instructions for use (ifu) addressed the known and potential events of "pain and perforation" as follows: warning: intestinal obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.Death due to intestinal obstruction is possible and has been reported with other intragastric balloons.Patients experiencing any symptoms of an intestinal obstruction (e.G., acute onset of abdominal pain, nausea or vomiting) should be counseled to seek immediate care.Warning: patients may not observe or report the presence of blue-green urine following a balloon deflation.Patients should be counseled to seek immediate care if any symptoms of an intestinal obstruction such as acute abdominal pain, nausea or vomiting develop.Warning: subjects who are found at retrieval endoscopy to have a gastric ulcer should be placed on 6 - 8 weeks of therapeutic proton pump inhibitor (ppi) medication and followed closely.After completing 6 - 8 weeks of ppi treatment, subjects experiencing potential ulcer symptoms or signs such as abdominal pain or discomfort, dyspepsia, anemia or dark stools should be considered for endoscopic examination to assess ulcer resolution.Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation (headache, muscle pain, nausea), anaphylaxis, cardiac arrest, death, hypoxia, myocardial infarction, perforation, infection, pneumonia, and respiratory distress.Potential risks associated with the reshape dual balloon include ulceration, perforation, significant gastric bleeding, need for blood transfusions, emergency endoscopic therapeutic intervention, abdominal pain, abdominal spasms, nausea, vomiting, bloating, belching, heartburn, dysphagia, dehydration, and sore throat.These complications may be severe enough to require early removal of the reshape dual balloon.A fully inflated, partially filled or a leaking distal balloon could lodge in the gastric outlet causing a pyloric obstruction which can produce a mechanical impediment to gastric emptying and lead to gastric outlet obstruction, requiring endoscopic balloon drainage and removal.Although the reshape dual balloon design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction.The risk of intestinal obstruction is increased if the device is not removed after 6 months.If intestinal migration occurs, the device may pass through the intestine and be passed with stool.However, surgical or endoscopic removal may be required.Death due to intestinal obstruction is possible and has been reported with other intragastric balloons.

Event Description

Apollo endosurgery received medwatch form (mw5092500), per form, patient was rushed to hospital to have the device removed due to perforated abdominal viscus causing pain and sepsis.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• MDR Report Key: 9881063
• MDR Text Key: 186735114
• Report Number: 3006722112-2020-00041
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2020

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: Health Professional
• Device Model Number: RSM101
• Device Catalogue Number: RSM101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/25/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 40 YR