MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; STENT CAROTID

Model Number SEPX-7-40-135

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 06/02/2014

Event Type  Injury  

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

"the physician intended to use a protege rx during procedure.It is reported that when the physician introduced the catheter, resistance was encountered.The surgical time was extended.The event prolonged patient hospital stay by one day due to patient vasospasm.

• Brand Name: PROTEGE RX
• Type of Device: STENT CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5149789
• MDR Text Key: 28242770
• Report Number: 2183870-2015-00387
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2015
• Device Model Number: SEPX-7-40-135
• Device Catalogue Number: SEPX-7-40-135
• Device Lot Number: 9693500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2013
• 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): Hospitalization