MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-02-26 for ESOFLIP ES-330 manufactured by Crospon Ltd.
[137171111]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[137171112]
According to the reporter, the patient's esophagus was perforated during the procedure for diagnostic/dilation. It was noted that egd (esophagogastroduodenoscopy) did not show very tight les (lower esophageal sphincter). The catheter was inserted and showed di 0. 3-0. 5. The physician was confused, as the numbers did not match what was seen on egd or barium swallow. The physician wanted to do empiric dilation because the patient was symptomatic, a typical chest pain after eating. Dilation went okay with the dilation catheter? 60cc, 24. 4cm. There was no scope during dilation and after, the scope was inserted and did not see obvious perforation, but it saw a good amount of bleeding that was more than usual. The patient did well after, had a mild chest discomfort and went home. The next day, the patient experienced more chest pain, left chest, got barium swallow, not definitive for perforation. A ct scan on the next day showed extravasation of contrast (leak). The patient was admitted to the hospital for 2 weeks on antibiotics and npo (nothing by mouth) for few days. A repeat ct scan still showed leak, so patient was put in esophageal stent. The endoscopist at that time stated that the tear looked to be 7cm, but the physician did not believe it was that big or else the patient would have been much more symptomatic. Another repeat ct/barium showed no leak, so the patient went on advance diet and went home after 2 weeks. The patient had retching/vomiting, so the tear might have gotten larger due to that.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006897778-2019-00001 |
| MDR Report Key | 8370943 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-26 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2019-02-26 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | CROSPON LTD |
| Manufacturer Street | GALWAY BUSINESS PARK, DANGAN |
| Manufacturer City | GALWAY,FL H91P2DK |
| Manufacturer Postal Code | H91P2DK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOFLIP |
| Generic Name | ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS |
| Product Code | PIE |
| Date Received | 2019-02-26 |
| Model Number | ES-330 |
| Catalog Number | ES-330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSPON LTD |
| Manufacturer Address | GALWAY BUSINESS PARK, DANGAN GALWAY,FL H91P2DK H91P2DK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-26 |