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

Model Number SPD2-US-050-320

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

Event 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 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
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15301678
• MDR Text Key: 298702168
• Report Number: 15301678
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068342
• UDI-Public: (01)00821684068342(17)240217(10)B340383
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 08/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Male