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

Model Number	SPD2-US-040-320
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A spider fx device was returned to the lab, where the green delivery catheter appears to have broken in vivo at the primary exit port.It seems that it was snared by a competitors snare to be recovered.The spider fx filter was located in the transparent section of the delivery catheter.All components are accounted for.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis: a spider fx and snare device were returned for analysis inside a previously opened spider fx box and pouch which indicated lot a791850.No other ancillary devices were included.The spider fx was returned with the delivery catheter fractured apart into two segments.The distal segment was approximately 22cm in length and showed the snare device was captured at approximately 21cm from the distal tip.The fracture face was radial and showed signs of stretching.The location of the fracture was at the primary wire exit port.The second segment inspected found the capture wire was loaded and the filter assembly was identified inside the clear segment of the catheter.The fracture face was radial and showed signs of stretching.The location of the fracture was at the primary wire exit port.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
• Common Device Name: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10342898
• Report Number: 2183870-2020-00236
• Device Sequence Number: 803767
• Product Code: NTE
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 02/28/2021
• Device Model Number: SPD2-US-040-320
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: A791850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention