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

Model Number 60831

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event 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
• Type of Device: 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
• MDR Text Key: 282566961
• Report Number: 2184009-2021-00124
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885074266022
• UDI-Public: 00885074266022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/03/2021
• Date Device Manufactured: 02/18/2021
• 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 Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White