MAUDE Adverse Event Report: COVIDIEN TRELLIS 8 120X25; CONTINUOUS FLUSH CATHETER

Model Number CVT812025V01

Device Problems Inflation Problem (1310); Leak/Splash (1354); Difficult to Advance (2920); Torn Material (3024)

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

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The physician tried two different devices that had difficulty passing through the 8f sheath.The distal balloon on one of the trellis would not inflate and upon examination there was a leak in the balloon.The physician used another trellis device through a different 8f sheath to remove the clot.Investigation of the returned trellis found the proximal balloon was torn and involuted on itself.

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.

• Brand Name: TRELLIS 8 120X25
• 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: 4310094
• MDR Text Key: 5193182
• Report Number: 2183870-2014-00315
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2016
• Device Model Number: CVT812025V01
• Device Catalogue Number: CVT812025V01
• Device Lot Number: 9923450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other