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

Model Number 4FC12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Electro-Mechanical Dissociation (1826)

Event Date 11/01/2017

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7011503
• MDR Text Key: 91407915
• Report Number: 3002648230-2017-00601
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 11/27/2017; 03/08/2018
• Supplement Dates FDA Received: 12/20/2017; 03/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death