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

Model Number BVT808015

Device Problem Torn Material (3024)

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

Event Date 05/10/2014

Event Type  malfunction  

Event Description

The trellis was used for proximal segment of the ilio-femoral.The balloons were deflated and device was pulled back into a proximal position.When the physician attempted to inflate the distal balloon, it was noticed that it has torn because it would not inflate.

Manufacturer Narrative

A review of the 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.

• Brand Name: TRELLIS 8 80X15
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN-PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4198639
• MDR Text Key: 19970872
• Report Number: 2183870-2014-00262
• 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: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: BVT808015
• Device Catalogue Number: BVT808015
• Device Lot Number: 551984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2013
• 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): Other