MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, PERCUTANEOUS

Model Number AB35W08060040

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2013

Event Type  malfunction  

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

It is reported that the balloon burst inside a preexisting stent, inside a dialysis graft.A new stent was placed inside existing stent, and post dilated with a new balloon with a good result.Evaluation summary: the evercross dilation catheter was received for evaluation.Sanguine material was present on the device.The catheter balloon material was in post-inflation profile; it was not tight-wrapped or winged.The device was inflated with water a water filled 10cc syringe: water was observed weeping from the balloon material.The device was then immersed in a water bath and inflated with an air filled 10cc syringe: air bubbles were observe exiting a pinhole leak near the proximal end of the balloon chamber.A 10cc water filled syringe was attached and the balloon fully inflated to locate the pinhole leak.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5322704
• MDR Text Key: 35012987
• Report Number: 2183870-2015-07617
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/19/2016
• Device Model Number: AB35W08060040
• Device Catalogue Number: AB35W08060040
• Device Lot Number: 9749161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1