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 Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/19/2016

Event Type  Injury  

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.

Event Description

It was reported that during a cryoablation procedure, after advancing the sheath across the septum, there was a pause in the procedure to wait for the activated clotting time (act).It was then noticed that the patients blood pressure was slowly dropping.The ablation procedure was aborted and an echo-cardiogram was performed.A mild to moderate effusion was discovered resulting in a pericardial tap being performed.It was noted that the physician indicated the effusion could have been a compilation of items.The patient was on an oral blood thinner and was additionally given an intravenous (iv) blood thinner during the procedure; a small effusion may have occurred from the wire during the trans-septal crossing, thus the slow progression of decreasing blood pressure.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: data file analysis demonstrated no system notices on the date of the event.The physical product was discarded.

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, quebec H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire, quebec H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6099169
• MDR Text Key: 59749831
• Report Number: 3002648230-2016-00480
• Device Sequence Number: 1
• Product Code: DRA
• 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: 10/19/2016

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: 08/12/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 67944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided; 11/14/2016
• Supplement Dates FDA Received: 12/05/2016; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2016
• 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): Hospitalization; Life Threatening; Required Intervention