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

Model Number 2AF284

Device Problems Kinked (1339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 01/05/2018

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, the patient had a pericardial effusion.A pericardial pigtail drain was placed.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least nine applications were performed with balloon catheter 2af284 / 79020-69 on the date of the event with no system issue.This is a clinical issue encountered during the procedure.No product malfunction reported.Upon visual inspection of the balloon catheter 2af284 / 79020-69, results showed that the catheter was kinked on guide wire lumen.Smart chip verification showed that the catheter has been not used.Dissection showed that guide wire lumen kinked on 1.4590 inches from the tip.The balloon catheter failed the performance test due to kink on guide wire lumen, there is no evidence the kink could cause the reported clinical adverse event.In conclusion, the reported issue has been not confirmed through testing and data analysis.The clinical issue (pericardial effusion) was encountered during the case.The balloon catheter failed the returned product inspection due to the guide wire lumen kink.There is no evidence the kink could cause the reported clinical adverse event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7216371
• MDR Text Key: 98122514
• Report Number: 3002648230-2018-00052
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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 Expiration Date: 11/20/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 79020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• 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
• Treatment: 4FC12-SHEATH, 990063-020-MAPPING CATHETER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 119