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

Model Number	SPD2-US-050-320
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
In process of performing the lhc (left heart catheterization) angiogram.We proceeded to fix the stenosis of the svg-om graft.We put a 5.0 spider filter wire (medtronic) and then proceeded to put a 4.0x12 in the ostium of the svg (saphenous vein) graft.The stent was deployed successfully, and it was time to retrieve the filter wire with the filter removal system that comes with the spider wire.The filter wire then got stuck within the stent.The patient was stable the entire time.We then had to proceed with different techniques to get the spider filter out.We ended up pulling the filter wire out with the stent attached.Visualized stent on filter after removal.New stent place- no harm to patient.
Event or Problem Description
In process of performing the lhc (left heart catheterization) angiogram.We proceeded to fix the stenosis of the svg-om graft.We put a 5.0 spider filter wire (medtronic) and then proceeded to put a 4.0x12 in the ostium of the svg (saphenous vein) graft.The stent was deployed successfully, and it was time to retrieve the filter wire with the filter removal system that comes with the spider wire.The filter wire then got stuck within the stent.The patient was stable the entire time.We then had to proceed with different techniques to get the spider filter out.We ended up pulling the filter wire out with the stent attached.Visualized stent on filter after removal.New stent place- no harm to patient.

• 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: 15301678
• Report Number: 15301678
• Device Sequence Number: 7166706
• Product Code: NTE
• UDI-Device Identifier: 00821684068342
• UDI-Public: (01)00821684068342(17)240217(10)B340383
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022
• Report Date (Section F): 08/19/2022

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 Lot Number: B340383
• 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: 08/26/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 08/26/2022
• 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: Male
• Date Report Sent to FDA: 08/19/2022