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

Model Number 4FC12

Device Problem Detachment Of Device Component (1104)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that during a cryoablation procedure, the stopcock detached from the sheath.The sheath was replaced with a new one and the procedure was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the flexcath advance sheath 4fc12 / (b)(4) was visually inspected and functionally tested.Upon visual inspection of sheath, results did not show any detachment of the stopcock distal end luer from the side port tube proximal end.Both the sheath's distal tip and dilator tip were intact.There were no fractures, breaks, or kinks noticed.No teflon delamination was noticed at the tip of the sheath shaft.The sheath tip was atraumatic and with no sharp edges.Upon functional testing of the sheath, results showed that the deflection worked as per specification.In conclusion, the reported ¿stopcock detachment¿ issue has not been confirmed through visual inspection and testing.The sheath passed the returned product inspection as per specification.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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: 5180818
• MDR Text Key: 30038163
• Report Number: 3002648230-2015-00374
• 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,Followup,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 87759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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