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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, loss of diaphragmatic contraction was noted, indicating phrenic nerve palsy ( pnp).The ablation was stopped using a double stop technique.The case was completed with cryo.The patient was breathing spontaneously with good saturation, and paradoxical diaphragmatic motion was noted under fluoroscopy.The pnp did not recover before the patient was discharged from the hospital, as noted on chest x-ray.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter, model: afapro28 with lot number: 13951, the visual inspection showed that the catheter was intact with no apparent issues.Smart chip verification showed that the catheter has been used for twelve applications on date of event.The catheter passed the performance test as per specification.The catheter passed the electrical continuity test.Pin-to-pin impedance measurement did not show any fluctuation.In conclusion, the reported issue patient experienced phrenic nerve palsy (pnp).This is a clinical issue encountered during the procedure, no product malfunction reported.The catheter passed the returned product inspection as per specification.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.

• 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
• MDR Report Key: 11759896
• MDR Text Key: 248472399
• Report Number: 3002648230-2021-00212
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00763000245436
• UDI-Public: 00763000245436
• Combination Product (y/n): N
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 13951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR