MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number AFAPRO28

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978); Protective Measures Problem (3015)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected a compromised outer vacuum.The inner balloon ruptured and it could not be returned back into the sheath.Using the manual retrieval kit, the balloon catheter could not be removed from the sheath.The sheath and balloon catheter were withdrawn from the patient in one attempt.The case was aborted and the patient was not under general anesthesia. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the afapro28 balloon catheter with lot number 20006 was returned and analyzed.The balloon catheter was trapped inside the returned 4fc12 sheath.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for seven applications on the reported event date.During functional testing, the console terminated the application and triggered system notice "the system did not recognize the catheter." during the electrical testing using an automatic electrical tester (aet), pin 1 and 2 was found to be out of specification.The value should be less than 190 ohms.The measured value of impedance was 261 ohms.Pins 4 and 1 was found to be out of specification.The value should be greater than 1.00 m ohms.The measured value of impedance was.121 m ohms.Pins 4 and 2 was found out of specification.The value should be greater than 1.00 m ohms.The measured value of impedance was.197 m ohms.Pressure testing and inspection was performed on the sub-components of the balloon, handle, and shaft segments.During pressure testing of the balloon segment, an inner balloon burst was observed.Dissection of the balloon segment id entified complete separation of the balloon material.Also, the break on the thermocouple wire was observed.The break was identified at the balloon area.During inspection and pressure testing of the shaft segment, a guide wire lumen breach was observed at 0.8 in ches proximal to the catheter tip.In conclusion, the balloon catheter failed the returned product inspection due to the inner balloon burst, broken thermocouple wire, and guide wire lumen breach.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.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18946974
• MDR Text Key: 338674962
• Report Number: 3002648230-2024-00100
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100010
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 20006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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