MAUDE Adverse Event Report: PERFUSION SYSTEMS CARDIOBLATE LP ABLATION BIPOLAR DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	60841
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ulceration (2116); Ulcer (2274); Blood Loss (2597)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure ((b)(6) 2018) a cardioblate lp clamp and cryoflex probe were used through a sternotomy to treat the patients af.Left pulmonary vein conduction block was not performed due to a possible clot in the left atrial appendage.Right pulmonary vein (pv) conduction block was not performed.The patient had a concomitant surgical procedure of amputated/excised and oversewn.On (b)(6) 2018 the patient experienced a gastrointestinal bleed.A colonoscopy was carried out and it showed multiple ulcers in ascending and descending colon.During the colonoscopy a hemostatic clip was placed at one bleeding site.The patient¿s haemoglobin was 7.5.The patient was hospitalized from the (b)(6) until the (b)(6).The patient was given a blood transfusion and concomitant or additional medication because of this adverse event.The adverse event was deemed as unlikely related to the study procedure and unlikely related to the concomitant procedure.The customer stated that the stress of surgery may have contributed.The adverse event was deemed as not related to the study devices.
Additional Manufacturer Narrative
Correction to b5.The patient had a concomitant surgical procedure of aortic valve replacement and mitral valve replacement through sternotomy.The left atrial appendage was successfully amputated/excised and oversewn.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.
Additional Manufacturer Narrative
Additional information: a patient information 4.Weight in kgs.Correction h2.6 patient codes (ime/annex e): these fields have been updated.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: CARDIOBLATE LP ABLATION BIPOLAR DEVICE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8332025
• Report Number: 2184009-2019-00003
• Device Sequence Number: 62041
• Product Code: OCL
• UDI-Device Identifier: 00885074359618
• UDI-Public: 00885074359618
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K093203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2024

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: 07/26/2021
• Device Model Number: 60841
• Device Catalogue Number: 60841
• Device Lot Number: 278B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019; 11/21/2024
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 08/23/2019; 11/22/2024
• Date Device Manufactured: 08/09/2018
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White