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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Air Embolism (1697)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

It was reported that the patient developed air in the right coronary during insertion or removal of the sheath.The air embolism was noticed by inferior st elevation.The air embolism resolved within 10 minutes and the cryoablation procedure was completed.The physician stated that he feels there is a problem with the valve on the sheath.The product was discarded.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation into the alleged failure was not possible since the device was not returned; it was discarded by the user facility.

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Date file analysis did not show any system notices for the date of event.Files also showed at least 20 injections were performed with catheter (b)(4).This was a clinical issue encountered during the procedure.No product has been returned for analysis.Final resolution: unable to analyze, product was not returned.An adverse event occurred during 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,qc 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: 4758431
• MDR Text Key: 5947535
• Report Number: 3002648230-2015-00137
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2016
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 94271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2014
• 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): Other
• Patient Age: 00073 YR
• Patient Weight: 83