MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	227F5
Medical Device Problem Code	Device Expiration Issue (1216)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, an expired balloon catheter was used.The case was completed with radiofrequency.No patient complications have been reported as a result of this event.

• Brand Name: FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 7133877
• Report Number: 3002648230-2017-00691
• Device Sequence Number: 16411239
• Product Code: LPB
• UDI-Device Identifier: 00643169504936
• UDI-Public: 00643169504936
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2017
• Device Model Number: 227F5
• Device Catalogue Number: 227F5
• Device Lot Number: 05919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR