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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a cryo ablation procedure, when the balloon catheter was manipulated in the left atrium, the patient's transient blood-pressure dropped and the heart rate increased.Noradrenalin, salt solution and vasolan were administered and blood pressure was regained.The healthcare professional noted this may have been due to dehydration.Additionally, bleeding occurred from the inguinal region where the sheath was inserted.When the patient left an operation room, stable cardiohemodynamics were observed.No pericardial effusion was confirmed and the patient responded normally when the physician talked to patient.The patient's four limbs motion was normal.A physician taking care of the patient commented that a vessel near the vein was possibly damaged from the side where the sheath was inserted.The case was completed with cryo.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files for the date of the reported event were returned and analyzed; no anomalous flow, pressure or temperature behaviors were recorded.It was also reported that no system notices were recorded.The balloon catheter, 2af284 with lot 21849, was not returned for investigation.Clinical issues (hematoma and hypotension) occurred during the procedure.In conclusion, the case was related to clinical issues (hematoma and hypotension) and the balloon catheter, 2af284 with lot 21849, was not returned.
Event or Problem Description
Additional information was received via follow up indicating that the physician first noticed bleeding following the insertion of a competitor sheath.The sheath was then replaced with a medtronic sheath but the bleeding continued.Following the procedure a ct scan showed no issues.The patient experienced anemia post procedure but recovered and was discharged.The physician commented that the bleeding was likely caused by two insertion sites in the vein being too close and interfering with each other in the subcutaneous tissue.The insertion angle was approximately forty five degrees.The physician further commented that the space between the two sites should be larger to accommodate the sheath and prevent bleeding, and that the event was likely cause by the insertion site issues rather than the sheath.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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 ; CA
• MDR Report Key: 6356778
• Report Number: 3002648230-2017-00092
• Device Sequence Number: 578782
• Product Code: OAE
• UDI-Device Identifier: 00643169504783
• UDI-Public: 00643169504783
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 21849
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided; 03/09/2017
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 04/06/2017; 10/02/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 36