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

Model Number 2AFAST28

Device Problems Suction Problem (2170); Device Displays Incorrect Message (2591)

Patient Problem Nerve Damage (1979)

Event Date 10/16/2015

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, during cryo application to the right inferior pulmonary vein (ripv) the physician observed a partial paralysis of the diaphragm.It is unknown if the paralysis recovered.Additionally, it was reported that on the last freeze, a system notice was received indicating that the safety system detected a compromised outer vacuum.The procedure was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device, balloon catheter 2afast28 with lot number 57554-90, and data files were returned and analyzed.Data files show a system notice was received indicating that the safety system detected a compromised outer vacuum (system notice 50032) occurred at injections fifteen and sixteen.Visual inspection of the catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for seventeen injections.Dissection and pressure testing showed a leak at the 0.5 psi check valve in the y-block.The phrenic nerve injury reported is a clinical issue encountered during the procedure which is independent of the system notice and failed returned product inspection findings.In conclusion, the catheter failed the return product inspection due to the system notice and 0.5 psi check valve leak and the phrenic nerve injury is a known clinical issue that was encountered during the procedure.

Manufacturer Narrative

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

• Brand Name: ARCTIC 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: 5222675
• MDR Text Key: 31192403
• Report Number: 3002648230-2015-00400
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2017
• Device Model Number: 2AFAST28
• Device Catalogue Number: 2AFAST28
• Device Lot Number: 57554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other