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

Model Number SPD2-US-060-320

Device Problems Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis device was returned with the filter basket partially loaded in the blue recovery catheter.Dry biologics were observed on the blue recovery catheter multiple kinks were observed on the blue recovery catheter a section of the blue recovery catheter was observed to be detached severe damage was observed to the green delivery catheter kinks were observed on the clear section of the green delivery catheter kinks were observed along the green delivery catheter damage to the radiopaque marker band at the tip of the green delivery catheter was observed.Dry biologics were observed on the delivery catheter.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 physician was attempting to use a spider fx to treat a lesion in the right cca.The ifu was followed.It was reported that a kink in the middle of the catheter occurred during initial advancement.Another product was used to complete the case.No patient injury was reported.When the device was returned to the manufacturing facility it was noted that the catheter was detached.

• 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: 16182565
• MDR Text Key: 308587764
• Report Number: 2183870-2023-00013
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068366
• UDI-Public: 00821684068366
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2023

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 Expiration Date: 04/26/2023
• Device Model Number: SPD2-US-060-320
• Device Catalogue Number: SPD2-US-060-320
• Device Lot Number: B196619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/17/2023
• Date Device Manufactured: 04/26/2021
• 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 Sex: Female