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

Model Number	49341
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a concomitant surgical procedure of mitral valve replacement, tricuspid valve repair.On the day of the procedure a cyroflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by an ft-10 generator were used.The left atrial appendage was successfully closed.Left pulmonary vein (lpv) block was achieved.Right pulmonary vein (rpv) conduction block was achieved.One day post procedure the patient experienced bleeding.A concomitant/additional medication was given.The patient was treated with blood transfusion, subject was oozy at end of case, no active bleeding, no need for vasopressors, bleeding from mouth and trialysis catheter, heparin held.H&h reported as stable at discharge, no signs of active bleeding.These caused prolonged hospitalization.The patient status was recovered/resolved approximately one month later and discharged from hospital.The adverse event was deemed by the site as probably related to the concomitant procedure, and not related to the study procedure and not related to the study devices.The adverse event was deemed by the sponsor as related to the study procedure and the concomitant procedure, possibly related to the cryoflex probe and cardioblate lp clamp but not related to the cryoconsole and the ft10-generator.The clinical events committee (cec) deemed incident as casually related to the concomitant procedure and the study procedure, possibly related to the cryoflex probe and clamp but not related to the console and the ft10 generator.
Additional 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
• Common Device Name: 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: 17571857
• Report Number: 2184009-2023-00898
• Device Sequence Number: 8268042
• Product Code: OCL
• UDI-Device Identifier: 00643169998018
• UDI-Public: 00643169998018
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K182610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: 49341
• Device Catalogue Number: 49341
• Device Lot Number: 631E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/18/2023
• Date Device Manufactured: 10/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White