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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
Catalog Number SPD2-060-320
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 01/24/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a spider fx embolic protection device during procedure to treat the distal internal carotid artery.Ifu was followed.It was reported that during procedure, it was noticed that the filter tip was detached from its guide wire after the stent positioning in the ica.Physician decided to retrieve the filter with a goose neck snare and not to post dilate the vessel because it was not needed.There was no patient injury reported.
 
Manufacturer Narrative
Additional information: the patient had the left distal internal carotid artery (ica) treated.The mildly calcified, stenosed lesion had mild tortuosity and calcification.There was 80% lesion stenosis.The artery diameter was 7 mm for the cca and 5.5.Mm for the ica.The lesion length was 20 mm.A non-medtronic 6 fr sheath was used.The vessel was not pre-dilated.There was no difficulty during filter advancement through the vessel.There was no vessel damage reported.The event date and patient demographics was provided.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
Image review: the customer provided a photo of the filter assembly broken off of the capture wire with a snare device in the background.The tip wire showed a bend between the coiled tip and the distal marker band of the filter.The filter appeared undamaged; however, the capture wire fractured within the filter mesh and was curved outward.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 Key9651904
MDR Text Key190508875
Report Number2183870-2020-00032
Device Sequence Number1
Product Code NTE
Combination Product (y/n)N
PMA/PMN Number
K063204
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/11/2020
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
Device Operator Health Professional
Device Expiration Date11/22/2021
Device Catalogue NumberSPD2-060-320
Device Lot NumberA937165
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/28/2020
Initial Date FDA Received01/31/2020
Supplement Dates Manufacturer Received02/20/2020
03/10/2020
Supplement Dates FDA Received02/21/2020
03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight86
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