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

Model Number	227F3
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the electrophysiology (ep) catheter 227f3 with lot number 56710 was returned and analyzed.Visual inspection of the catheter showed the shaft was broken above the electrodes at 3 different places, the verification of the smart chip file showed that this catheter was used for one injection.The visual inspection showed that the catheter was intact with no apparent issues.Additional tests were unable to be conducted with the catheter as it had been damaged.All electrodes are tight and sealed.The tip of the catheter was also intact on the detached part of the shaft.In conclusion, the broken shaft issue was confirmed.The ep catheter failed the returned product inspection due to shaft breakage.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, the steerability of the electrophysiology (ep) catheter was not as expected.In an attempt to straighten out the ep catheter, the tip of the catheter broke off and a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.The broken tip remained in the sheath during removal.The case was aborted.No patient complications have been reported as a result of this event.

• 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
• MDR Report Key: 10955752
• Report Number: 3002648230-2020-00635
• Device Sequence Number: 690667
• Product Code: LPB
• UDI-Device Identifier: 00643169672475
• UDI-Public: 00643169672475
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2020

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: 08/17/2022
• Device Model Number: 227F3
• Device Catalogue Number: 227F3
• Device Lot Number: 56710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR