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

Model Number 60831

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

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Perforation (2513); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information through a post market clinical follow-up (pmcf) survey that following use of the cardioblate bp2 ft clamp device at an unspecified time the patients experienced the blood loss as a result of a perforation of the heart cavity.The customer stated that surgical or medical intervention was not required.The customer stated that this adverse effect was directly related to the device.

Manufacturer Narrative

Additional information was received indicating that the model number used was 60831 rather than 49321.All associated fields have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through a post market clinical follow-up (pmcf) survey that following use of the cardioblate bp2 device device at an unspecified time the patient experienced the blood loss as a result of a perforation of the heart cavity.The customer stated that surgical or medical intervention was not required.The customer stated that this adverse effect was directly related to the device.

• Brand Name: BP2 ABLATION DEVICE BIOPOLAR DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10572178
• MDR Text Key: 208092373
• Report Number: 2184009-2020-00060
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K093203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60831
• Device Catalogue Number: 60831
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other