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

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2021

Event Type  malfunction  

Event Description

Spiderfx distal embolization device fractured when trying to retrieve the basket, which was left in the popliteal artery.The basket was retrieved in its entirety using a snare device.Fda safety report id # (b)(4).

• Brand Name: SPIDERFX
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 12210766
• MDR Text Key: 263227779
• Report Number: MW5102710
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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