MAUDE Adverse Event Report: PERFUSION SYSTEMS CARDIOBLATE LP ABLATION BIPOLAR DEVICE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60841

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

Patient Problem Tissue Damage (2104)

Event Date 07/23/2019

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 the cardioblate lp device the customer reported that the flow was slow from the tip of the bipolar pen.The saline was checked with no issues noted.The venous pipeline was smooth and there was saline outflow but the flow was small and slow.The client still insisted on using it.When the ablation was in progress for 4-5 minutes, there was a high impedance alarm, and the tissue showed signs of burning.The device was replaced.After the operation, the patient returned to normal and sinus heart rate was restored.

Manufacturer Narrative

Visual analysis: visual inspection shows evidence of blood staining on both jaws.Additional visual inspection shows saline residue in the tubing.Performance analysis: the device was attached to a 68000-generator using the bypass startup, the device was connected and was recognized).Using the gauze test, a couple of ablation cycles were initiated with no issues observed.Note: there was little to no saline flow observed from the jaws when attached to 300 mm/hg pressure cuff.The device was cut apart and when the electrodes were lifted from the jaws there was adequate saline flow observed.Conclusion: reason for return was confirmed for saline flow.Additional information; b5;the operator was an experienced user of the device.The customer was attempting to ablate the following areas; the tricuspid anterior annulus, the superior vena cava, and the inferior vena cava.The customer stated that they did not pay attention to number of times the device reported high impedance.A.4.Weight provided 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.

• Brand Name: CARDIOBLATE LP ABLATION BIPOLAR 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: 8830245
• MDR Text Key: 152309641
• Report Number: 2184009-2019-00048
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: 60841
• Device Catalogue Number: 60841
• Device Lot Number: 123C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 49