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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
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COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE Back to Search Results
Model Number SPD2-US-050-320
Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199); Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The spider fx device was used during a procedure.A medtronic integrity stent was placed in the cerebral artery.It is reported the spider fx filter dislocated and could not be retrieved.Surgical removal was required.The patient needed a blood transfusion for blood loss.No further injury reported.
 
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.
 
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.
 
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Brand Name
SPIDER FX
Type of Device
CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
MDR Report Key10835155
MDR Text Key216094640
Report Number2183870-2020-00387
Device Sequence Number1
Product Code NTE
UDI-Device Identifier00821684068342
UDI-Public00821684068342
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/06/2022
Device Model NumberSPD2-US-050-320
Device Catalogue NumberSPD2-US-050-320
Device Lot NumberA972394
Was Device Available for Evaluation? No
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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