MAUDE Adverse Event Report: COVIDIEN (IRVINE) ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number 190-5092-150

Device Problems Break (1069); Component Missing (2306)

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

Event Date 10/22/2014

Event Type  malfunction  

Event Description

Treatment of an aci/com aneurysm.The patient¿s anatomy was normal in tortuosity.On (b)(6) 2014, the patient underwent embolization treatment.During the procedure, the distal marker of the echelon microcatheter was observed to be missing.The marker band was found in the rhv (rotating hemostatic valve).Another echelon microcatheter was used to complete the procedure.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no issues were noted that would have contributed to this event.The device has been received and evaluation is in progress.A supplemental mdr will be submitted once the evaluation is complete.

Manufacturer Narrative

Two echelon-14 catheters and two catheter segments were returned for evaluation.Follow-up attempts were made to verify the complaint device and also the relation of the second device to the complaint.However, no correspondence has been received with any additional information.The two catheters were found broken into two segments at approximately 155.80cm from the proximal end on one catheter and at 155.30cm on the other catheter.The two distal broken segments of the catheters were noted to be pre-shaped.The tubing material at the broken ends exhibited jagged edges, exposed braid, and stretching.Approximately 2.92mm of the catheter tip was found missing on one catheter and 2.45mm of the catheter tip was found missing on the other catheter.The two broken ends exhibited plastic deformation (stretching) of the tubing material indicating that the catheters broke when they were pulled with forces exceeding the tensile strength of the tubing materials.All catheters are 100% inspected for damage and irregularities during manufacture.(b)(4).

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4388229
• MDR Text Key: 5434004
• Report Number: 2029214-2015-00001
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2016
• Device Model Number: 190-5092-150
• Device Lot Number: 9959893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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