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

Model Number 2AF284

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 01/25/2016

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 cryoablation procedure, phrenic nerve palsy (pnp) was noticed during second lesion of the right superior pulmonary vein (rspv).The pnp had not resolved by the time the procedure ended.The physician stated the patient recovered after the patient was released.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least four injections were performed with non-returned catheter (b)(4) at the date of the case.Upon visual inspection of balloon catheter (b)(4) results showed that the device was intact with no apparent issues and mapping catheter was stuck inside the balloon catheter.Smart chip verification indicated the balloon catheter was used for twelve injections.The balloon catheter was tested with the mapping catheter still stuck in it.The balloon catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.Further dissection / pressure testing did not show any leaks or traces of liquid/blood inside the catheter.This is a clinical issue encountered during the procedure.In conclusion, this is a clinical issue encountered during the procedure.The balloon catheter passed the returned product inspection as per specification.

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: 5438225
• MDR Text Key: 38235127
• Report Number: 3002648230-2016-00046
• Device Sequence Number: 1
• Product Code: OAE
• 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,Followup
• Report Date: 04/20/2016

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: 10/29/2016
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 93591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/16/2016
• Supplement Dates Manufacturer Received: Not provided; 04/20/2016
• Supplement Dates FDA Received: 04/22/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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): Other
• Patient Age: 00083 YR
• Patient Weight: 88