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

Model Number SPD2-US-050-320

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

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

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A turbohawk plus and a spider fx were being used for the treatment of a 60mm plaque lesion in the distal region of the superficial femoral artery (sfa) and popliteal artery.The artery diameter was 5mm in and the degree of tortuosity was moderate.There was mild calcification.A 6fr non medtronic sheath was used for thecase.The vessel was not pre dilated.Both devices were prepped as per the ifu with no issues identified.It was reported the spider filter was placed in posterior tibial artery. device advanced through lesion and several passes performed without incident.The turbohawk was going to be removed from the sheath but resistance was felt.A wire loop was discovered under x-ray and the spider wire had kinked.Attempting to pull the sheath, turbohawk and spider back over the aortic bifurcation resulted in the hawk tip detaching.A buddy wire was placed alongside the spider wire to maintain up-and-over access.The turbohawk catheter was removed while the spider wire remained in place with the hawk tip floating on it.The sheath, hawk tip, and spider wire were attempted to be removed over the buddy wire.The sheath came out but the spider wire broke at the groin site.The turbohawk tip and filter basket embolized down the mid-sfa in the ipsilateral leg.Access was obtained in the opposite groin, a long 8f sheath was placed up-and-over, and a snare catheter was advanced down to the hawk tip + filter basket.A tulip snare was used to remove the device fragments from the body.The buddy wire allowed for the access to the original groin to be preserved, and the case still continued with post-atherectomy angioplasty.

Manufacturer Narrative

Product analysis capture wire was returned along with the filter basket loaded in the detached tip of the turbohawk device severe damage was observed to the capture wire.Kinks were observed along the length of the capture wire tip of turbohawk device was detached.The filter basket was entrapped in the tip tissue debris was observed in the filter basket.Kink observed on the capture wire.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Type of Device: 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: 16335970
• MDR Text Key: 309165499
• Report Number: 2183870-2023-00051
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068342
• UDI-Public: 00821684068342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPD2-US-050-320
• Device Catalogue Number: SPD2-US-050-320
• Device Lot Number: B414326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male