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

Model Number	227F3
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the 227f3 electrophysiology (ep) catheter with lot number 45117 was returned and analyzed.Visual inspection of the ep catheter showed the shaft was kinked at strain relief.Smart chip verification indicated the catheter was used for 1 injection.The catheter failed the performance test due to the system notice 50030 indicating "excessive flow".The pressure test revealed a leak through the shaft at strain relief.In conclusion, the ep catheter failed the returned product inspection due to the shaft breach.
Event or Problem Description
After a completed case, the electrophysiology (ep) catheter tested out of specification per the manufacturer's investigation.

• Brand Name: FREEZOR XTRA CARDIAC CRYOABLATION CATHETER
• 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
• 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: 12829989
• Report Number: 3002648230-2021-00526
• Device Sequence Number: 4571838
• Product Code: LPB
• UDI-Device Identifier: 00643169672475
• UDI-Public: 00643169672475
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 12/11/2021
• Device Model Number: 227F3
• Device Catalogue Number: 227F3
• Device Lot Number: 45117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown