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 Death (1802); Pericardial Effusion (3271)

Event Date 06/23/2016

Event Type  Death  

Event Description

It was reported that post cryo ablation procedure the patient developed a pericardial effusion.The patient had a pericardiocentesis and fluid continued to build and the patient was taken to the operating room for a repair for the effusion.It was additionally reported that the patient died eleven days post procedure.Follow up occurred, but no further information has been obtained at this time.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files did not show system notices or issues for the date of the event.There was no indication of a product malfunction, and no product was returned for investigation.A known clinical issue was encountered during the procedure.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5882484
• MDR Text Key: 52316296
• Report Number: 3002648230-2016-00336
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• 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: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 32752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• 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; Hospitalization; Life Threatening; Required Intervention