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

Model Number 2AF281

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Medtronic cryocath was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age is male/(b)(6) old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: safety and efficacy outcomes of protamine administration for heparin reversal following cryoballoon-based pulmonary vein isolation.J.Intervent.Card.Electrophysiol.2015;43(2):161-167.(b)(4).

Event Description

The literature publication reports the following complications: pericardial tamponade, mild pericardial effusion, deep vein thrombosis, vascular access complications, hematoma/pseudoaneurysm, arteriovenous fistula.There was intervention taken.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Correction: device not approved for distribution in the u.S.And not similar to a product approved for distribution in the u.S.

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: 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: 5052330
• MDR Text Key: 24924569
• Report Number: 3002648230-2015-00281
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/05/2015

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: 2AF281
• Device Catalogue Number: 2AF281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Supplement Dates Manufacturer Received: 08/06/2015
• Supplement Dates FDA Received: 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): Hospitalization; Required Intervention
• Patient Age: 00056 YR