MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-26 for ESOFLIP ES-330 manufactured by Crospon Ltd.
[139872685]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[139872686]
According to the reporter, they had a patient with history of achalasia and findings of esophageal spasming and stricturing. First dilation of the patient was up to mid twenties and after this dilation, the diameter was roughly 10 or 12. Eventually, they got to 30 after which the resting diameter was about 16. There had been a relatively little amount of mucosal trauma before the 30 dilation that went more so that would typically have been expected. The patient was sent for a chemical study which did not show perforation and after this, a chest ct scan was eventually performed and showed no obvious esophageal leakage. A repeat chemical study was performed which eventually showed a leak and after the result, the patient went to the operating room for the repair of the tear in the esophagus from the dilation. The patient was hospitalized for approximately 10 days. No repeat procedure was necessary and the patient's last known status was ok and doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006897778-2019-00004 |
| MDR Report Key | 8452525 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-26 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2019-03-26 |
| 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 | 2019-03-26 |
| Model Number | ES-330 |
| Catalog Number | ES-330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-26 |