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

Model Number 105-5091-150

Device Problem Mechanical Problem (1384)

Patient Problem Tinnitus (2103)

Event Date 03/06/2014

Event Type  Injury  

Event Description

Covidien received information from a clinical study that a patient underwent onyx embolization treatment for intracranial non-cavernous dural arteriovenous fistulas.During the procedure, it was reported the echelon catheter tip became stuck in the patient and was left there.One month later, it was reported the patient had retromastoid left sided tiny tinnitus.The event was considered mild in severity and the patient recovered without sequelae.No further information was reported as a result of the procedure.

Manufacturer Narrative

The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported event.The device was not returned for analysis; therefore, the event cause could not be determined.Same event as mdr# 2029214-2015-00068.(b)(4).

• Brand Name: ECHELO MICRO CATHETER
• 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
• MDR Report Key: 4491159
• MDR Text Key: 5331690
• Report Number: 2029214-2015-00069
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2015
• Device Model Number: 105-5091-150
• Device Lot Number: 9840911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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 Outcome(s): Disability
• Patient Age: 23 YR