MAUDE Adverse Event Report: EV3, INC. SPIDERFX EMBOLIC PROTECTION DEVICE; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Lot Number B172889

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

Getting stuck/ tangled on wire.Fda safety report id # (b)(4).

• Brand Name: SPIDERFX EMBOLIC PROTECTION DEVICE
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): EV3, INC. ; plymouth MN
• MDR Report Key: 12032630
• MDR Text Key: 257502551
• Report Number: MW5101985
• Device Sequence Number: 1
• Product Code: NTE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Lot Number: B172889
• 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