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

Model Number 4FC12

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the flexcath sheath was returned and analyzed.Visual inspection of the sheath showed that the stopcock distal end luer were completely detached from the proximal end of the side port tube.In conclusion, the reported issue was confirmed and the sheath failed the inspection due to a stopcock detachment from the side port tube.(b)(4).

Event Description

It was reported that prior to use for a cryo ablation procedure, the side port had fell off the sheath.The sheath was replaced and the procedure was completed with cryo.No patient complications have been reported as a result of this event.It was further reported that the subsequently tested out of specification upon the manufacturer's analysis.

• 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: 5287351
• MDR Text Key: 33852277
• Report Number: 3002648230-2015-00451
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 01594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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