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

Catalog Number	SPD2-US-070-320
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the spider fx capture wire was returned.The filter showed traces of the biological debris with the filter mesh.No damages to the filter assembly components were noted.The capture wire was bent in a loop approximately 46.5cm from the distal tip.The loop sowed the ptfe was scraped off, likely due to encountered friction during attempted removal of the hawkone.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the hawkone with a spider fx 7mm and a terumo sheath and a 0.35 guidewire, to treat a heavily calcified lesion with 70% stenosis in the left mid superficial femoral artery.The device was prepped as per ifu with no issues noted.Artery diameter 6mm, lesion length 200mm.It was reported during the procedure the guidewire was wrapped around the hawkone and resistance was encountered removing the device from the patient but was ultimately removed through the sheath.It was reported that the cutter was in the housing during removal.The procedure was completed with dcb.No injury to the patient reported.When the spider device was returned to the manufacturing facility for evaluation, it was noted that the device was damaged.
Additional Manufacturer Narrative
Supplemental regulatory report (b)(4) was submitted with the incorrect aware date of 30.11.2018.This has been corrected to 11.02.2019 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: 8350404
• Report Number: 2183870-2019-00076
• Device Sequence Number: 1740001
• Product Code: NTE
• UDI-Device Identifier: 00821684068380
• UDI-Public: 00821684068380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2020
• Device Catalogue Number: SPD2-US-070-320
• Device Lot Number: A729916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 98