MAUDE Adverse Event Report: CROSPON LTD ESOFLIP; BALLOON DILATION CATHETER

Model Number	ES-330
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).
Event or Problem Description
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.
Additional Manufacturer Narrative
Follow up report to include data submitted by user facility to fda under importer report number (b)(4).
Event or Problem Description
Follow-up report submitted to add user facility report number.

• Brand Name: ESOFLIP
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): CROSPON LTD; galway business park; dangan; galway, H91 P 2DK; EI H91 P2DK
• MDR Report Key: 6642796
• Report Number: 3006897778-2017-00001
• Device Sequence Number: 16406416
• Product Code: PIE
• UDI-Device Identifier: 05391530810043
• UDI-Public: 5391530810043
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K132337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 04/06/2018
• Device Model Number: ES-330
• Device Catalogue Number: ES-330
• Device Lot Number: 3300170406
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization