MAUDE Adverse Event Report: MEDTRONIC, INC. CARDIOBLATE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number 49260

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Event Description

Medtronic received information that during use of this cardioblate gemini device after the last ablation, when the surgeon went to pull the device out of the thoracoscopic port to unclip the guides they noticed that the end of the gemini was broken and the other end of the bipolar jaw was attached to the end of the guide.The customer stated that only one end of the device was broken.The customer stated that it appeared to be a clean break.Twenty four hours after the procedure the patient developed bradycardia and then arrested on the ward resulting in the need for a pacemaker.Additional information: the customer used the device to ablate around the pulmonary veins and they had performed a total of 48 ablation shots.The device delivered energy 48 separate times (was activated to deliver energy 48 times).The device was clipped in and out of the guides a total of 4 times.The gemini device will be returned but the guides have been discarded.According to the surgeon, the patient's bradycardia was not caused by the gemini device.The surgeon is putting the issue with the patient potentially due to damage of blood supply to the sino-atrial node during the ablation which is a surgical technique issue.No fragments fell into the patient when the device broke.

Manufacturer Narrative

Analysis of returned device shows one of the tips is broken off.The broken off section of the tip was observed under magnification with little to no evidence of any tool marks.Reason for return was confirmed.Investigation: one thing to be careful of is the gemini device tips are not malleable so any attempts to bend and or move the silicone shrouds at the tips can and will result in damage to the device.Medtronic will continue to monitor for trends.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Further investigation determined an investigation has been opened into the issue.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: CARDIOBLATE
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13074038
• MDR Text Key: 282806080
• Report Number: 2182208-2021-05057
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2022

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 Expiration Date: 04/29/2023
• Device Model Number: 49260
• Device Catalogue Number: 49260
• Device Lot Number: 972C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 04/19/2022; 05/25/2022
• Supplement Dates FDA Received: 05/18/2022; 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1131-2022
• Patient Sequence Number: 1
• Patient Sex: Female