MAUDE Adverse Event Report: COVIDIEN LP BARRX BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 64082

Device Problems Deflation Problem (1149); Unraveled Material (1664); Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Date 02/07/2024

Event Type  Injury  

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.

Event Description

According to the reporter, the balloon catheter had malfunction.Esophagus was perforated while extubating.Device did not deflate all the way.Electrode came off of the balloon.Patient was in intensive care unit (icu).

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, the catheter electrode still attached to the balloon, however looked abnormal.It did not deflate all the way.The esophagus of the patient was perforated while extubating.Patient was in intensive care unit (icu).

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the catheter was received with the electrode improperly furled.A concentration of blood was noted at the sharp edge of the electrode.The electrode was torn but it was not detached from the balloon.The connector pins were intact.Functionally, the balloon was manually inflated with a syringe and able to hold pressure.The catheter electrically erasable programmable read-only memory (eeprom) data was read and there were no observed errors.Electrodes 1,3, and 5 failed scoot program test.It was reported that the catheter balloon failed to deflate.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the catheter electrode unraveled.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: always position or move the balloon catheter under direct endoscopic visualization.Prior to repositioning or removal, ensure complete deflation of the balloon.The balloon catheters should be used under direct endoscopic visualization using a rfa endoscopic guidewire or other stiff guidewire (0.035-0.039¿) indicated for gastrointestinal procedures.Rotation of the device in a counter clockwise direction may increase the device diameter and lead to insertion difficulties.Prior to inflation, visually confirm the electrode remains properly wrapped.If the electrode has axially displaced such that underlying electrode layers are exposed, reposition or rotate the device clockwise to obtain proper wrapping.During withdrawal, observe the balloon and electrode for any interaction with the esophageal tissue so as to ensure atraumatic removal.Rotation of the device in a counter-clockwise direction may increase the device diameter and lead to removal difficulties.After confirming that the entire length of barrett¿s esophagus is treated, position the endoscope immediately proximal to the balloon catheter electrode and balloon and ensure that the balloon and electrode are completely collapsed.Disconnect the catheter from the output cable, and then withdraw the endoscope and balloon catheter and guidewire together as a unit.Rotation of the device in a clockwise direction may reduce the device diameter and aid in removal.Hyperextens ion of the neck may also assist in device removal.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BARRX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer (Section G): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18778194
• MDR Text Key: 336218988
• Report Number: 3004904811-2024-00004
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 64082
• Device Catalogue Number: 64082
• Device Lot Number: B000002787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Sex: Male