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	Cardiac Arrest (1762); Death (1802); Electro-Mechanical Dissociation (1826)
Date of Event	11/01/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryoablation procedure, the patient experienced mechanical-electrical dyssynchrony.The patient was attempted to be resuscitated, but died in the lab.
Additional Manufacturer Narrative
Event summary: the patient data files showed at least three applications were performed with catheter 2af284/96333-07 without any issue on the date of the event.This case is a clinical issue encountered during the procedure (the patient experienced mechanical-electrical dyssynchrony.The patient was attempted to be resuscitated, but deceased in the lab.) the sheath 4fc12/30497 was not returned for analysis.In conclusion, this is a case related to a clinical issue (mechanical-electrical dyssynchrony and death).The sheath was not returned for analysis and investigation.There is no indication of product malfunction.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7011503
• Report Number: 3002648230-2017-00601
• Device Sequence Number: 16423310
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• 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,Followup,Followup
• Report Date (Section B): 03/12/2018

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: 07/31/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 30497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/27/2017; 03/08/2018
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 12/20/2017; 03/12/2018
• 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: Death