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	Death (1802); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/26/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: 2af284 balloon catheter product event summary: the data files were returned and analyzed.The data files showed that 16 applications were performed with balloon catheter, 2af284 with lot number 00329, without any issue on the date of the event.Clinical issues were encountered during the procedure.There is no indication of relation of adverse event to the performance and malfunction of the product.The physical product was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that after a successful cryo ablation procedure, pericardial effusion was evident through intracardiac echocardiography (ice) imaging.Measures were taken to optimize blood pressure and heart rate.Pericardiocentesis, open chest procedure, cardiopulmonary resuscitation (cpr), and blood transfusions were performed.The patient is deceased.The cause of death was cardiac tamponade.

• 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: 9879087
• Report Number: 3002648230-2020-00173
• Device Sequence Number: 11523347
• Product Code: DRA
• UDI-Device Identifier: 00763000043773
• UDI-Public: 00763000043773
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 03/25/2020

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: 04/14/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 85414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 990063-020 MAPPING CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR
• Patient Weight: 77