MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-15 for ESOFLIP ES-330 manufactured by Crospon Ltd.
[77619572]
Datafiles showing the time course of the dilation and lumen diameter measurements were reviewed with the physician who performed the cases. The case showed a narrowing proximal to the gastroesophageal junction which, it is postulated, may not have been able to tolerate the 30 mm diameter dilation. Datafiles from the case show that no malfunction of the endoflip system or esoflip balloon dilation catheter occurred. Furthermore, biomedical engineering at the hospital successfully completed a functional check of the pump 6/12/2017 to verify the system. The most probable root cause of this event is anticipated procedural complication as the reported event is a known physiological effect of the procedure (aliment pharmacol ther 2011;34:832-9).
Patient Sequence No: 1, Text Type: N, H10
[77619573]
It was reported to crospon that an esoflip es-330 balloon dilation catheter was used in a 30 mm achalasia dilation procedures which resulted in esophageal perforation. The perforation was not detected during the procedure, but became evident during subsequent testing with gastrograffin. The perforation was treated with surgery, and the patient has been discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006897778-2017-00001 |
| MDR Report Key | 6642796 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-15 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2017-04-17 |
| Date Added to Maude | 2017-06-15 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JOHN O'DEA |
| Manufacturer Street | GALWAY BUSINESS PARK DANGAN |
| Manufacturer City | GALWAY, H91 P2DK |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 P2DK |
| Manufacturer Phone | 91519880 |
| Manufacturer G1 | CROSPON |
| Manufacturer Street | GALWAY BUSINESS PARK DANGAN |
| Manufacturer City | GALWAY, H91 P2DK |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91 P2DK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOFLIP |
| Generic Name | BALLOON DILATION CATHETER |
| Product Code | PIE |
| Date Received | 2017-06-15 |
| Model Number | ES-330 |
| Catalog Number | ES-330 |
| Lot Number | 3300170406 |
| Device Expiration Date | 2018-04-06 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSPON LTD |
| Manufacturer Address | GALWAY BUSINESS PARK DANGAN GALWAY, H91 P2DK EI H91 P2DK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-06-15 |