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

Catalog Number	SPD2-US-050-320
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that an attempted was made to use a spider fx embolic protection device in a patient to treat a calcified fibrous plaque right mid internal carotid artery with severe tortuosity.A non-medtronic sheath was used and a non-medtronic guidewire.Moderate resistance was noted and ifu was followed.It was reported that the distal tip of the spider wire detached after removal of the device due to tracking difficulties due to anatomy.The detached component was removed, device did not detach until removed from the body and the physician barely touched it.Proceeded with carotid stenting without the use of an embolic protection device.The device was prepped as normal with no issue.Physician is very experienced with spider fx.Patient presented with tortuous anatomy causing the spider to not track well into the internal carotid artery.When advancing the spider through the introducer sheath, we noticed the wire buckling on itself a little bit and the physician felt resistance when trying to advance.We removed the device and inspected it.The physician said he just barely touched the tip of the wire, and it broke right off, delays in surgery due to product malfunction for 20 minutes but no bad clinical outcomes from this event were reported.The patient was not harmed.
Additional Manufacturer Narrative
Product analysis two still images were provided for analysis.One of the still images provided shows a tip detachment alongside the spider fx device.The second still image shows the physician holding a detached tip.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SPIDER FX
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21091172
• Report Number: 2183870-2025-00009
• Device Sequence Number: 8629325
• Product Code: NTE
• UDI-Device Identifier: 00821684068342
• UDI-Public: 00821684068342
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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 Expiration Date: 08/06/2026
• Device Catalogue Number: SPD2-US-050-320
• Device Lot Number: B770291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/05/2025
• Date Device Manufactured: 08/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female