MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-25 for RESHAPE INTEGRATED DUAL BALLOON SYSTEM RSM101 manufactured by Apollo Endosurgery, Inc..
[186735114]
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.
Patient Sequence No: 1, Text Type: N, H10
[186735115]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006722112-2020-00041 |
| MDR Report Key | 9881063 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-24 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. DAVID HOOPER |
| Manufacturer Street | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 |
| Manufacturer City | AUSTIN, TX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESHAPE INTEGRATED DUAL BALLOON SYSTEM |
| Generic Name | INTRAGASTRIC BALLOON |
| Product Code | LTI |
| Date Received | 2020-03-25 |
| Model Number | RSM101 |
| Catalog Number | RSM101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO ENDOSURGERY, INC. |
| Manufacturer Address | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 AUSTIN, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-25 |