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

Model Number AB35W06150135

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2013

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, fo llowing 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 during the procedure, the balloon burst below rated burst pressure.No patient injury is reported.

• 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
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN ; 7633987000
• MDR Report Key: 5322044
• MDR Text Key: 35012606
• Report Number: 2183870-2015-07610
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K110319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2013
• Device Model Number: AB35W06150135
• Device Catalogue Number: AB35W06150135
• Device Lot Number: 9431862
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2013
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: No
• 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