MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP PULSESELECT; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH

Model Number PSCC100

Device Problem Leak/Splash (1354)

Patient Problems Non specific EKG/ECG Changes (1817); Embolism/Embolus (4438); Heart Block (4444)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 10fcc13; product type: sheath medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during pulsed field ablation procedure, st elevation and heart block were observed for twenty minutes after placing the pulsed field ablation catheter into the left atrium.It was suspected by the physician to be caused by an air bubble.The symptoms resolved after twenty minutes.No intervention was carried out. the case was completed with pulsed field ablation. no further patient complications have been reported as a result of this event.

Event Description

It was later reported that the patient experienced third degree heart block.It was surmised that the adverse events were caused by an air bubble; however, no air bubble was seen in the devices or the patient.

Manufacturer Narrative

Correction: updated imf code.Product event summary: the pscc100 pulsed field ablation catheter of lot number 0012123138 and data files containing two images were returned and analyzed.Both photos showed microbubbles were observed in the side port tube of the sheath.Visual inspection of the handle area was performed.Visual inspection was carried out on the catheter pscc100 of lot number 0012123138 and steerable sheath 10fcc13 of lot number 0012106995 appeared intact without any visible issues.Steering function was normal, with the distal catheter tip responding with approximately 170° rotation in both directions.Slide function is as expected, and the shape of the capture device is unremarkable with no atypical features.Mechanical verification of steering and slide mechanisms was carried out.The slide control function operated as expected without any issues.Upon full advancement of the slide control to extend the guidewire lumen, no kinking was observed along the extended portion, indicating proper functionality and alignment of the steering and slide mechanisms.The catheter to sheath connection evaluation was carried out.The catheter was smoothly introduced through the valve and threaded along the shaft of the sheath without encountering any resistance.Upon exiting the sheath tip, the array was deployed as anticipated, indicating proper functionality.Data from the catheter identification chip confirms usage on the reported event date.The catheter was reprogrammed before connection to the generator via the returned catheter interface cable (cic), and therapy deliveries were successfully performed.In conclusion, the reported st elevation and heart block issue that occurred during the procedure and could not be confirmed through product analysis or data analysis.A review of the data files showed microbubbles were observed in the side port tube of the sheath.The pulsed field ablation catheter passed the return product inspection.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PULSESELECT
• Type of Device: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18967619
• MDR Text Key: 338471251
• Report Number: 3002648230-2024-00107
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: PSCC100
• Device Catalogue Number: PSCC100
• Device Lot Number: 0012123138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female