MAUDE Adverse Event Report: PERFUSION SYSTEMS BP2 ABLATION DEVICE BIOPOLAR DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	60831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Atrial Fibrillation (1729)
Date of Event	10/25/2021
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
The patient had a concomitant surgical procedure of aortic valve replacement, coronary artery bypass grafting and reconstruction of ascending aorta with 28nn interposition graft through sternotomy.During the same procedure a cryoflex probe powered by a cryoconsole, and a cardioblate bp2 clamp and cardioblate maps pen powered by a cardioblate generator were used.The left atriotomy was incised, amputated and sutured.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block was not performed, as coronary artery bypass after maze unable to access pulmonary vein.Approximately 7 days post procedure the patient experienced ventricular escape rhythm underlying pacer after going into atrial fibrillation.The patient status was recovered/resolved two days later.The adverse event was deemed by the site possibly related to cardioblate bp2 clamp, cryoflex probe, concomitant procedure and study procedure.

• Brand Name: BP2 ABLATION DEVICE BIOPOLAR 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13052284
• Report Number: 2184009-2021-00124
• Device Sequence Number: 17119304
• Product Code: GEI
• UDI-Device Identifier: 00885074266022
• UDI-Public: 00885074266022
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K093203
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: 02/18/2024
• Device Model Number: 60831
• Device Catalogue Number: 60831
• Device Lot Number: 565D
• 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: 12/03/2021
• Initial Report FDA Received Date: 12/21/2021
• Date Device Manufactured: 02/18/2021
• 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: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White