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

Model Number 3FC12

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Vessels (2135)

Event Date 05/11/2015

Event Type  Injury  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product event summary: the device, of flexcath 3fc12 / (b)(4), was returned and analyzed.Visual inspection of the device showed it was intact with no apparent issues.Functional testing indicated the deflection worked as per specification.Dissection did not show any breakage of the pull wire.Multiple aspirations and injections were performed without air bubbles or leaks; the hemostatic valve was leak tight.No product malfunction reported or found on analysis.The reported perforation issue is a clinical issue encountered during the procedure and the returned product passed inspection per specification.(b)(4).

Event Description

It was reported that during a cryoablation procedure, due to the patient's vessel condition, there was an arterial puncture in an unknown location of the body.Follow up was conducted and no further information is available at this time.The operation was aborted.No patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH 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: 5065523
• MDR Text Key: 25336626
• Report Number: 3002648230-2015-00292
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Notification
• Report Date: 05/11/2015

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: 12/01/2016
• Device Model Number: 3FC12
• Device Catalogue Number: 3FC12
• Device Lot Number: 06983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2014
• 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 Age: 00043 YR