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

Model Number 2AF283

Device Problems Kinked (1339); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

Event Type  malfunction  

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, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The balloon catheter was replaced with resolve.Also, blood was observed between the folds of the balloon.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: visual inspection of balloon catheter 2af283 / 40757 showed the inner balloon had traces of blood inside.The catheter failed the performance test due to system notice (#50011) indicating that the refrigerant delivery path was obstructed.Pressure tests revealed a leak through the guide wire lumen.The balloon integrity was intact, and no breach was observed.Dissection showed a guide wire lumen twist and guide wire lumen breach at approximately 1.5345 inches proximal from the tip.In conclusion, the reported system notice issue has been confirmed through testing.The catheter failed the inspection due to twist and guide wire lumen breach.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Event summary: failure files confirmed the system notice (#50005) indicating that ¿the safety system detected fluid in the catheter and stopped the injection¿ on the date of the event.In conclusion, the reported issue (#50005) was also confirmed through data analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2018: incoming information indicated that blood was observed between the folds of the balloon.(b)(6) 2018: following analysis of the product/clinical data an out of specification finding was discovered.The catheter was reassessed for reportability.

• 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: 7430903
• MDR Text Key: 105526091
• Report Number: 3002648230-2018-00224
• Device Sequence Number: 1
• Product Code: OAE
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 40757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 06/27/2018
• Supplement Dates FDA Received: 04/20/2018; 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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