MAUDE Adverse Event Report: CROSPON LTD ESOFLIP; ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS

Model Number ES-330

Device Problems Product Quality Problem (1506); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the catheter failed when they were trying to start a procedure.The syringe would not load properly and they got a temperature sensor failure error.A repeat procedure was necessary with additional anesthesia and the customer stated that they did not insert the catheter into the patient, but they did use another catheter without issue.There was no reported patient outcome.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by post market vigilance investigation personnel.One es-330 was received for evaluation.The returned sample did not meet specification as received by medtronic.The visual inspection found that balloon was wet and electrodes were corroded.The customer reported that there was syringe issue.The investigation found that the thermistor wire was deteriorated.Another issue was the amount of electrode corrosion due to the deposition of saline residue, leading to its deterioration causing fi difficult to be conclusive.The root cause of this hampered wire can be probably handling issue or stretching of catheter.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ESOFLIP
• Type of Device: ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS
• Manufacturer (Section D): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK
• MDR Report Key: 8495507
• MDR Text Key: 141359862
• Report Number: 3006897778-2019-00006
• Device Sequence Number: 1
• Product Code: PIE
• Combination Product (y/n): N
• PMA/PMN Number: K132337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ES-330
• Device Catalogue Number: ES-330
• Device Lot Number: 3300180202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 05/30/2019; 09/23/2019
• Supplement Dates FDA Received: 06/19/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1