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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that upon completion of a cryo ablation procedure a pericardial effusion was noted on intracardiac echo (ice).It was noted that after transseptal access a competitor guidewire was passed into a position that was not visible by the physician on fluoroscopy, the wire was removed and realigned and was able to be visualized in the left atrium, the sheath was exchanged with the guidewire and was visualized with fluoroscopy.Unremarkable pulmonary vein isolation with the use of a mapping catheter and balloon catheter was performed.It was additionally noted that the patient presented to the procedure in atrial fibrillation (af) and required intraprocedure cardioversion and was converted to normal sinus rhythm.Upon completion of the procedure the effusion was visualized on ice and a pericardial tap was performed.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: data files for the date of the reported event were returned and analyzed.The data files did not show any system notices for the date of the reported event.No product was returned for investigation.A clinical issue was encountered during the procedure; no product malfunction was reported.In conclusion, there was no indication of a product malfunction and no product returned; a clinical issue was encountered during the procedure.

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; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5247944
• MDR Text Key: 32100506
• Report Number: 3002648230-2015-00421
• 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: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 87754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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): Life Threatening; Required Intervention