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

Model Number	SPD2-US-050-320
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While deploying the spider wire, the tip of the wire broke off in the carotid.

• Brand Name: SPIDERFX¿
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15190464
• Report Number: 15190464
• Device Sequence Number: 5541878
• Product Code: NTE
• UDI-Device Identifier: 00821684068342
• UDI-Public: (01)00821684068342
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/25/2022
• Report Date (Section F): 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPD2-US-050-320
• Device Catalogue Number: SPD2-US-050-320
• Device Lot Number: B324880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/25/2022