MAUDE Adverse Event Report: COVIDIEN SPIDERFX; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number SPD2-US-070-320

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

Spider filter wire introduced into right iliac artery-could not get the wire and filter to land where md wanted- the md pulled the wire and filter back and out of the leg and asked for a new filter wire.Scrub tech noticed the used wire was not intact compared to the new wire placed on the table.The tip was missing and the md was informed.Md was able to snare the tip from the distal leg artery and continued with pta procedure.

• Brand Name: SPIDERFX
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan ln. north; plymouth MN 55442
• MDR Report Key: 9284334
• MDR Text Key: 165253028
• Report Number: 9284334
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPD2-US-070-320
• Device Catalogue Number: SPD2-US-070-320
• Device Lot Number: A831237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32485 DA