MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-04-12 for ESOFLIP ES-330 manufactured by Crospon Ltd.
[141766899]
Title hydraulic dilation with a shape-measuring balloon in idiopathic achalasia: a feasibility study source kappelle wouter fw et al. Hydraulic dilation with shape-measuring balloon in achalasia, endoscopy, 2015 (1028? 1034) date of publication: 29 april 2015. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[141766900]
According to literature source of study performed, 10 consecutive patients with newly diagnosed idiopathic achalasia were dilated twice with the balloon, resulting in 20 dilations in total. Three patients reported recurrent dysphagia. Complications caused by the dilation included post-procedural pain on 3 patients, and reflux symptoms on 5 patients. Both symptoms were treated satisfactorily with analgesics and proton pump inhibitors. After 3 months, three patients were still using proton pump inhibitors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006897778-2019-00007 |
| MDR Report Key | 8509207 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-04-12 |
| Date of Report | 2019-09-24 |
| Date of Event | 2015-04-29 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2019-04-12 |
| 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 | 2019-04-12 |
| 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 | 2019-04-12 |