MAUDE Adverse Event Report: PERFUSION SYSTEMS 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 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use of a cardioblate gemini ablation device, it was reported after application of the last ablation line, the device with the guiding wires attached to the electrodes via the silicone ends was removed from the patient.Only one guidewire (blue) came out attached to the electrode.The grey guide wire was detached from the electrode because it was broken.The grey guide wire could be removed without any problem or harm to the patient.The device was not replaced in the procedure because it broke after the last line was ablated.There was no patient impact associated with this event.Additional information received reported that the broken piece was removed by pulling the clamp out of the patient.The guiding wires were still attached to the clamp.While pulling the clamp out of the patient the surgeon observed that the grey guiding wire didn¿t come out with the clamp.The guiding wire was removed separately.20 ablation lines had been completed (approx.600 to 700 sec ablation time).The user had moved to the opposite side of the heart.The string was being used.

Manufacturer Narrative

Device evaluation summary: visual inspection shows one of the jaw tips is broken off.Reason for return was confirmed.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.

• Brand Name: CARDIOBLATE
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14520749
• MDR Text Key: 292812451
• Report Number: 2184009-2022-00122
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 49260
• Device Catalogue Number: 49260
• Device Lot Number: 974E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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 Sex: Female