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

Model Number ES-330

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

Data files showing the time course of the dilation and lumen diameter measurements were reviewed with the physician who performed the cases.The case showed that the perforation appeared to occur at less than 25mm dilation diameter.In discussion with the physician, it was noted the second patient had a diverticulum.Data files 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 Description

It was reported to crospon that an esoflip es-330 balloon dilation catheter was used in a 30mm achalasia dilation procedures which resulted in esophageal perforation.The perforation was not detected during the procedure, but became evident during subsequent testing with barium.The perforation was treated with surgery, and the patient has been discharged.

• Brand Name: ESOFLIP
• Type of Device: BALLOON DILATION CATHETER
• Manufacturer (Section D): CROSPON LTD; galway business park; dangan; galway, H91 P 2DK; EI H91 P2DK
• Manufacturer (Section G): CROSPON; galway business park; dangan; galway, H91 P 2DK; EI H91 P2DK
• Manufacturer Contact: john o'dea ; galway business park; dangan; galway, H91 P-2DK ; EI H91 P2DK ; 91519880
• MDR Report Key: 6642842
• MDR Text Key: 77627083
• Report Number: 3006897778-2017-00002
• Device Sequence Number: 1
• Product Code: PIE
• UDI-Device Identifier: 05391530810043
• UDI-Public: 5391530810043
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K132337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/16/2017

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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization