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

Model Number 4FC12

Device Problems Air Leak (1008); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the valve of the sheath was visibly torn and that there was air ingress during aspiration of the sheath.The sheath was replaced and the cryoablation procedure was successfully completed.There were no patient symptoms or complications related to the event.

Manufacturer Narrative

The device has not yet been analyzed.Results of evaluation of returned device will be submitted in a supplemental report.

Manufacturer Narrative

The returned device was visually inspected and functionally tested.Visual inspection showed that the device was intact with no apparent issues.The reported issue has been confirmed through testing; air aspiration was reproduced when a test catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking; valve was torn.An internal capa has been initiated to investigate the condition found.This report will be recorded and trended.

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 CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 3708428
• MDR Text Key: 4333218
• Report Number: 3002648230-2014-00052
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2014
• Initial Date FDA Received: 03/28/2014
• Supplement Dates Manufacturer Received: Not provided; 03/29/2014
• Supplement Dates FDA Received: 04/22/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• 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