MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; CATHETER, STEERABLE

Model Number 2AFAST28

Device Problems Bent (1059); Obstruction of Flow (2423)

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

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that during a cryo ablation procedure, a system notice had occurred indicating that the refrigerant delivery path was obstructed.Also, the balloon catheter had bent and the physician was unable to remove or steer the catheter.Troubleshooting steps were provided.The system notice resolved and the catheter was removed.The procedure was aborted and the patient was under general anesthesia.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: product event summary: the balloon catheter and data files were returned and analyzed.The data files confirmed the system notice indicating that the refrigerant delivery path was obstructed ((b)(4)) at the beginning of the first injection.Also, the data files showed at least twelve injections were performed with the catheter.Visual inspection of the catheter showed that the device was intact with no apparent issues.The catheter failed the deflection test due to the back of the lever not working.Also, the dissection revealed that a pull wire was broken inside the handle.The dissection of the balloon segment showed two guide wire lumen kinks at 0.59 and 0.81 inches from the tip.The pressure test did not show leaks.In conclusion, the catheter failed the returned product inspection due to a guide wire lumen kink and a broken pull wire.This event was reported due to a non reportable product problem and the risk associated with placing the patient under general anesthesia without therapy.The option to abort the case without another therapy was based on the medical decision of the physician.The product issue found on analysis was independent of the adverse event being reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5239466
• MDR Text Key: 31737281
• Report Number: 3002648230-2015-00407
• Device Sequence Number: 1
• Product Code: DRA
• 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,Followup,Followup,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2017
• Device Model Number: 2AFAST28
• Device Catalogue Number: 2AFAST28
• Device Lot Number: 49048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2015
• 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