MAUDE Adverse Event Report: PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number 49260

Device Problems Break (1069); High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: visual inspection showed that one of the jaw tips was broken off.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.There was saline flow observed from the jaws when attached to 300 mm/hg pressure cuff.The reason for return was confirmed for a broken tip.Conclusion: the broken jaw was confirmed during analysis of the returned device.Medtronic will continue to monitor for future trends and occurrences for this device.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.

Event Description

Medtronic received information that during use of a cardioblate gemini device, it was reported that in the first set of ablation on the right side (convex), after four ablations, it was noted that the device was showing high impendence for five consecutive ablations.Another three full ablations were performed and then the device was removed out of the thoracotomy.Once the device was removed from the chest it was noticed the device tip had broken with the tip of the device still attached to the guide.The surgeon was able to remove the broken tip and another device was used without further incident.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the cable was not broken prior to use.The jaws of the device were not clamped onto a surface besides tissue.The jaws closed and locked eleven times before the broken tip was noticed.This issue did not noticeably affect the ablation procedure.The surgeon used minimally invasive forceps to pick the piece out from the thoracotomy.The customer confirmed that 0.9% saline was used.A pre-test was done during which high impedance was not observed.High impedance was noted during the procedure after two cycles.The pre-test was successful.The presence of saline flow to the device was verified.The tissue thickness was not verified prior to ablation, as it was not possible with this procedure.It had been less than ten minutes since the device was removed from the packaging.

• Brand Name: CARDIOBLATE
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17595172
• MDR Text Key: 321636832
• Report Number: 2184009-2023-00903
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: 49260
• Device Catalogue Number: 49260
• Device Lot Number: 875E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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): Required Intervention
• Patient Sex: Male
• Patient Weight: 127 KG