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 Disconnection (1171); Suction Problem (2170); Device Displays Incorrect Message (2591)

Patient Problem Pericardial Effusion (3271)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the u.S.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 cryoablation procedure, a system notice was received indicating that the safety system detected a compromised outer vacuum.The electrical cable was disconnected and reconnected without resolve.Additionally, a second system notice was received indicating that the safety system detected a compromised outer vacuum.The umbilical cables were changed without resolve.The auto connection box was then replaced which did not resolve the notice.There were noted issues with the y-connector coming off as well which were replaced.The balloon catheter was replaced and the procedure was completed with cryo.Pericardial effusion was noted post procedure, which resolved on it's own without intervention.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: upon visual inspection of the balloon catheter 2af283 / 88013-54, results showed the device was intact with no apparent issues.The push button luer is not broken and intact.Verification of the smart chip file indicated the catheter was used for seven injections.The balloon catheter did fail the performance test due a system notice indicating that the safety system detected a compromised outer vacuum (# (b)(4)).The pressure test and dissection revealed a leak in the inner balloon at the distal attachment with the catheter tip.Pericardial effusion is a clinical issue encountered during the procedure.In conclusion, the reported system notice (# (b)(4)) indicating that the safety system detected a compromised outer vacuum has been confirmed through testing.The broken push button luer issue on the catheter has not been confirmed through testing.The reported system notice (#(b)(4)) indicating that the safety system detected a compromised outer vacuum has not been confirmed through testing.The catheter failed the returned product inspection due to inner balloon leak at the attachment with the tip.The above stated system notices are unrelated to the reportable adverse event of pericardial effusion.Pericardial effusion is a clinical issue encountered during the procedure.

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: 5274365
• MDR Text Key: 33364605
• Report Number: 3002648230-2015-00448
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2017
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 88013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• 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): Hospitalization