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

Model Number	SPD2-US-040-320
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician was attempting to use a spider fx to treat the peripheral artery, tibial/popliteal trunk.There was minimal tortuosity.Fem-pop bypass was reported in relation to anatomy.A 6f cook ansel sheath and a.035 260cm glidewire advantage guidewire was used.Embolic protection was used.The vessel was not pre-dilated and post dilated.The device passed through a previously deployed stent.Moderate resistance was encountered when advancing the device and excessive force was not used.No damage noted to packaging and no issues noted when removing the device from the hoop/tray.Ifu was followed.The 4mm spider was delivered over the wire to the peroneal artery.The green catheter was advanced down to the peroneal and the crossing wire was removed.The filter was pushed forward until it reached the level of the tpt (still inside the delivery catheter) but would not go further.The physician attempted to remove the delivery catheter but encountered resistance.Advancing x-ray over the groin revealed a wire prolapse in the common femoral artery, which was enlarged due to a bovine patch.This resulted in intervention for removal of device.The physician encountered trouble trying to remove the spider catheter and wire as the wire started to kink.The cook sheath and spider delivery were removed as one unit with force; however, the spider catheter broke where the green meets the white.The physician replaced the cook sheath with a new 6f sheath, then a 8f sheath, then used a penumbra cat 8 catheter to advance over the kinked spider wire and pull everything out.The device was safely removed from the patient and the procedure was aborted; the patient recovered after closing the 8f groin.
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.
Additional Manufacturer Narrative
Product analysis: the device returned with a sheath and guidewire.Multiple kinks were evident to the capture wire a detachment was evident to the green delivery catheter with stretching evident.The detachment occurred at the guidewire entry port of the green delivery catheter.The material was jagged and uneven at the detachment site.The spider was returned in the clear section of the green delivery catheter.An attempt was made to advance and retract the filter basket but was unsuccessful due to dried biologics and stretching of the proximal section of the clear section.No deformation was evident to the distal tip or marker band.Image analysis: three still images were provided for review, the images are photos of images on a screen and are of poor quality.Upon review of the images provided, there is a prolapsed wire visualized across the aortic bifurcation and right iliac region.There are two wires noted in what appears to be the right groin region, no contrast is utilized so unable to better define which vessel the device is located in any image.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: 19721674
• Report Number: 2183870-2024-00214
• Device Sequence Number: 8148106
• Product Code: NTE
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111010
• 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): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2026
• Device Model Number: SPD2-US-040-320
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: B696352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male