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 06/16/2015

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, pericardial effusion (pe) was diagnosed by an intracardiac echocardiogram (ice) following left atrial (la) introduction of both catheters and sheath.All device manipulations appeared normal and were unremarkable.No cryo balloon inflations or ablations were performed.All devices were removed from the left atrium within five minutes of the pe diagnosis.It was also noted that 280 milliliters of fluid were removed from the pericardial space and the patient remained stable throughout the procedure.The procedure was aborted without any ablations taking place.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The device is not available for investigation; it was discarded after the procedure.There was no indication of product malfunction.Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.The data files did not show any system messages for the date of the event.(b)(4).

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 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: 4912951
• MDR Text Key: 22242048
• Report Number: 3002648230-2015-00178
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 30163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2015
• Date Device Manufactured: 04/09/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00074 YR