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

Model Number EVT808015V01

Device Problem Torn Material (3024)

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

Event Date 11/13/2014

Event Type  malfunction  

Event Description

This procedure was performed in (b)(6).The procedure was treatment of iliofemoral dvt that was accessed via the common femoral vein.The physician successfully performed the trellis procedure over a 10 minute period completing 1st treatment cycle.The physician then withdrew the catheter from the 8f sheath to inject contrast through sheath.The physician went to put catheter back over wire into sheath and at that time noticed distal balloon had torn.It had been inflated successfully during the procedure.

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.

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.(b)(4).

Event Description

Evaluation summary: the trellis peripheral infusion system manifold/catheter was received for evaluation, no ancillary devices or cine images from the procedure were received.The trellis manifold/catheter was received for evaluation nested in a series of pouches.Upon removal from packaging it was noted that the distal balloon was ruptured.Under magnification it was noted that the fracture faces of ruptured distal balloon matched: indicating that all balloon material is accounted for.Neither defect nor abnormality was noted in the proximal balloon.

• 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: 4325395
• MDR Text Key: 20784105
• Report Number: 2183870-2014-00318
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: EVT808015V01
• Device Catalogue Number: EVT808015V01
• Device Lot Number: 9955275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR