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

Model Number	2AF284
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the balloon catheter 2af284 with lot number 53068 and data files were returned and analyzed.The data files confirmed system notice 50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ on application 11 with the catheter.Data files showed at least 11 applications were performed with this catheter on the date of the event.The data files confirmed system notice 50005 ¿leak detection¿ and 50006 ¿blood detection¿ on the date of the event.Visual inspection of the balloon catheter showed the mapping catheter is stuck inside the balloon.Both balloons were ruptured and were full of blood in the balloons and also at the coaxial port of the balloon handle and the balloon catheter was unable to be retracted from the sheath.The balloon was disinfected and flushed several times to remove the blood.The smart chip reading showed the balloon catheter was used for 11 injections.The balloon catheter was defective due to both balloons burst and rupture and was unable to test.There was no kink on guide wire lumen.In conclusion, the balloon catheter failed the returned product inspection due to double balloons rupture.This event is being reported as an adverse event due to the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.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, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection along with another system notice indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.Blood was found in the coaxial connector.The balloon appeared to be damaged.The case was aborted while the patient was under general anesthesia.No patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
• Common Device Name: 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
• MDR Report Key: 9178717
• Report Number: 3002648230-2019-00699
• Device Sequence Number: 14146945
• Product Code: OAE
• UDI-Device Identifier: 00643169976382
• UDI-Public: 00643169976382
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 53068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other