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

Model Number AB35W05060080

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

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 an incident occurred during the procedure.The returned device exhibited damage consistent with a balloon burst.No patient injury is reported.Device evaluation: the evercross dilation catheter was received for evaluation without any ancillary devices or cine images from the procedure.There was an accumulation of dried contrast in the manifold assembly's inflation port but this did not appear to be relevant to the reported event.The residue was removed and the catheter's inflation lumen was flushed with water.The balloon chamber exhibited a 35mm longitudinal tear starting at the proximal marker band.

• 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: 5323674
• MDR Text Key: 34963827
• Report Number: 2183870-2015-07614
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/07/2013

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: Physician
• Device Expiration Date: 01/07/2016
• Device Model Number: AB35W05060080
• Device Catalogue Number: AB35W05060080
• Device Lot Number: 9719845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other