MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR MAX CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 239F3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem ST Segment Elevation (2059)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files indicated balloon catheter 2af284 with lot number 46522 was used for eleven applications and electrophysiology (ep) catheter 239f3 with lot 81626 was used for twelve applications without issues.In conclusion, the reported clinical issue (st elevation) could not be confirmed through data analysis.The ep catheter was not returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that prior to a cryo ablation procedure, st elevation was observed.Medication was administered with resolve.The case was completed with cryo.No further patient complications have been reported as a result of this event.

• Brand Name: FREEZOR MAX CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8741162
• MDR Text Key: 149485053
• Report Number: 3002648230-2019-00464
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00643169504905
• UDI-Public: 00643169504905
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010
• 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
• Report Date: 06/27/2019

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: 07/03/2019
• Device Model Number: 239F3
• Device Catalogue Number: 239F3
• Device Lot Number: 81626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2017
• 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): Required Intervention