MAUDE Adverse Event Report: CORDIS/JOHNSON AND JOHNSON ANGIOGUARD RX; EMBOLI CAPTURE GUIDEWIRE SYSTEM

Catalog Number 10705032056830

Device Problems Incomplete or Missing Packaging (2312); Physical Resistance (2578)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2018

Event Type  malfunction  

Event Description

During a right carotid artery stent procedure, two angioguard rx emboli capture guidewire systems were opened.One of the stops on one of the filters were not packaged and it could not be used.Did not enter the patient.The second device showed resistance when tested so it was not used either.It did not reach the patient.

• Brand Name: ANGIOGUARD RX
• Type of Device: EMBOLI CAPTURE GUIDEWIRE SYSTEM
• Manufacturer (Section D): CORDIS/JOHNSON AND JOHNSON; miami FL 33102
• MDR Report Key: 7247356
• MDR Text Key: 99329340
• Report Number: MW5075098
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 10705032056830
• Device Lot Number: 35232420
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1