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

Model Number 2AF284

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 11/17/2015

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, the patient experienced a phrenic nerve injury after an ablation to the vein.The double-tap technique was performed.The procedure was aborted and the patient was extubated.It was noted that physician planned a sniff test prior to the patient's discharge.Follow up was conducted with no further information regarding the patient's condition.No patient complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4).

• 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: 5255514
• MDR Text Key: 32353657
• Report Number: 3002648230-2015-00433
• 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
• Report Date: 11/17/2015

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: 08/04/2016
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 57492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 11/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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): Required Intervention
• Patient Age: 00059 YR
• Patient Weight: 112