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

Model Number 2AFAST28

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that during a cryo ablation procedure, the physician believed that a piece of tissue had become detached.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: ARTIC FRONT ADVANCE SHORT TIP CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 5310271
• MDR Text Key: 33865084
• Report Number: 3002648230-2015-00461
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P100010 S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2015

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 Model Number: 2AFAST28
• Device Catalogue Number: 2AFAST28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided; 01/18/2016
• Supplement Dates FDA Received: 01/20/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• 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