MAUDE Adverse Event Report: PERFUSION SYSTEMS BP2 ABLATION DEVICE BIOPOLAR DEVICE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60831

Device Problems Off-Label Use (1494); Insufficient Flow or Under Infusion (2182)

Patient Problem Tissue Damage (2104)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use of a cardioblate bp2 device after making 2 to 3 lesions the operator noted that the saline could not reach the jaws and the target tissue burned.The operator checked and replaced the tubing but could not fix the issue.The device was replaced to complete the procedure.

Manufacturer Narrative

Visual inspection showed no outward signs of damage to the device.Additional visual inspection showed saline residue in the tubing.Performance analysis: a couple of ablation cycles were initiated.There was saline flow observed from the lower/fixed jaw.The device was cut apart and the upper jaw then started to operate.Conclusion: reason for return was confirmed for poor saline flow.This appears to be a one off issue.Review of complaint data for the 60831device has found no similar instances for this defect.There was no adverse effect to the patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a cardioblate bp2 device, after making 2-3 lesions the operator noted that the saline could not reach the jaws and the target tissue burned.The operator checked and replaced the tubing but could not fix the issue.The device was replaced to complete the procedure.There was no adverse effect to the patient.

• Brand Name: BP2 ABLATION DEVICE BIOPOLAR DEVICE
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8863654
• MDR Text Key: 153353319
• Report Number: 2184009-2019-00050
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K093203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 60831
• Device Catalogue Number: 60831
• Device Lot Number: 213A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization