MAUDE Adverse Event Report: PLYMOUTH TRELLIS 8 80X25; CATHETER, CONTINUOUS FLUSH

Model Number CVT808025V01

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

The distal balloon could not be inflated.The physician had completed 2 segmental areas and switched device to other leg.Balloon could not be inflated.An additional device was opened.The second trellis distal balloon could not be inflated after 1 section.The device was removed from the sheath with some difficulty.The trellis balloon was damaged and unable to inflate.Investigation of the first returned trellis device used in this procedure on (b)(6), found the distal balloon chamber material was missing: a small segment of balloon material on the catheter exhibited radial tearing.The proximal balloon chamber material was missing: a small segment of balloon material on the catheter exhibited radial tearing.Investigation of the second trellis in this procedure found approximately half of the distal balloon material was not returned.The distal balloon chamber material exhibits radial tearing.The proximal balloon appears to be intact.Reference mdr 2183870-2014-00247 for the other trellis used in this 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.

• Brand Name: TRELLIS 8 80X25
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane north; plymouth, MN 55442 ; 33987000
• MDR Report Key: 4148110
• MDR Text Key: 4768409
• Report Number: 2183870-2014-00248
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2016
• Device Model Number: CVT808025V01
• Device Catalogue Number: CVT808025V01
• Device Lot Number: 9933577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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