MAUDE Adverse Event Report: COVIDIEN TRELLIS 8 80X15; CONTINUOUS FLUSH CATHETER

Model Number EVT808015V01

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

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

Event Date 02/27/2015

Event Type  malfunction  

Event Description

This procedure occurred in (b)(6) and was thrombectomy of the left subclavian vein.Access was obtained through the basilic vein to treat thrombus in the subclavian.No issues getting wire access.The product was prepped per ifu.During inflation of the balloons it was observed that the distal balloon had a slow leak.No lytic was given at this point.The device was removed and we attempted to inflate the distal balloon out of the body.The balloon actually looked intact, but the leak seemed to be coming from the connection just proximal to the balloon.A new device was opened and used for 1 treatment cycle.The procedure was successful.

Manufacturer Narrative

A review of teh manufacture records for this device did not reveal any discrepancies relevant to the reported event.Additional information has been requested.Should it become available a supplemental report will be submitted.

Manufacturer Narrative

Patient demographic information received.

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.  a capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

Event Description

Evaluation summary: the trellis catheter was received for evaluation without the odu or any other ancillary devices or cine images from the procedure.Both balloon chambers were taut and free of blood residue.A water-loaded syringe was attached to the proximal inflation port and the system was pressurized.The balloon was inflated (air bubble ok for testing).No leaks in the proximal balloon were noted.The water-loaded syringe was attached to the distal inflation port and the system was pressurized.A leak was over the proximal marker band.The leak was oval-shaped and located at the distal-side of marker band 4.

• Brand Name: TRELLIS 8 80X15
• Type of Device: CONTINUOUS FLUSH CATHETER
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4638243
• MDR Text Key: 5759820
• Report Number: 2183870-2015-00108
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2017
• Device Model Number: EVT808015V01
• Device Catalogue Number: EVT808015V01
• Device Lot Number: A037564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 49 YR