MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number	4FC12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cryo ablation procedure, the patient had a pericardial effusion, which was confirmed via intracardiac echocardiography (ice).The case was aborted, and the patient was under general anesthesia.Subsequently, the patient required cardiopulmonary resuscitation (cpr), and open chest thoracotomy.The patient was then transported to the operating room (or) for a subsequent procedure or surgery.The patient's hospitalization was extended.The patient is recovering, and the extent of permanent injuries were unable to be determined.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files did not show any system notice for the date of the event.The sheath was not returned and there was no indication of a product malfunction.Some known clinical issues (cardiac perforation, pericardial effusion, tamponade and pulmonary vein tear) were encountered during the procedure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received indicated that during the open chest thoracotomy, a pulmonary vein (pv) tear was found and repaired.Additionally, the patient has since been discharged home.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 7139815
• Report Number: 3002648230-2017-00715
• Device Sequence Number: 93981
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123591
• 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,Followup
• Report Date (Section B): 01/10/2018

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: 04/11/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 58287
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR