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

Model Number AFAPRO28

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problem Nerve Damage (1979)

Event Date 04/03/2024

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, the dilator could not be inserted and locked into the sheath.The sheath was replaced which resolved the issue. it was also reported that a system notice was received indicating that the safety system detected a compromised outer vacuum.The balloon catheter was replaced which resolved the issue. then, while ablating the right inferior pulmonary vein (ripv), the compound muscle action potential (cmap) was reduced by more than half.The pacing catheter position was adjusted and phrenic nerve potential slightly recovered but then decreased again.Phrenic nerve paralysis was observed and the ablation was stopped.The case was completed with cryo and radiofrequency (rf) touch up ablations were done to avoid areas that may affect the phrenic nerve. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id: 4fc12 (lot: 0012105714), product type: 0629-flexcath sheath; product id: afapro28 (12146), product type: 0624-arctic front catheter.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.

Manufacturer Narrative

Product event summary: the afapro28 balloon catheter with lot number#: 16910, and an image file were returned and analyzed.The image showed, a balloon catheter.The lot/serial number of the product (16910), was identified in the picture.No anomalies were identified, during external visual inspection of the balloon, shaft and handle segments.The catheter smart chip data was downloaded and reviewed.Data indicated, the catheter was used for four applications on the reported event date.During functional testing, the console terminated the application and triggered system notice #50032 (the safety system detected a compromised outer vacuum).During inspection and pressure testing of the handle segment, a leak path was identified at the pressure sensor tube to the pressure sensor bond.In conclusion, the clinical issue of phrenic nerve injury (pni) occurred, during the procedure with no indication, that the adverse event was related to the performance or a malfunction of the product.The balloon catheter failed the returned product inspection, due to a bond leak observed, at the pressure sensor bond to the pressure sensor tube fitting.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 later reported, that an x-ray was performed the following day.And the phrenic nerve paralysis (pnp) had not recovered.The patient was discharged without a prolonged hospitalization.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19121259
• MDR Text Key: 340339077
• Report Number: 2649622-2024-10496
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 16910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2024
• 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