MAUDE Adverse Event Report: COVIDIEN SPIDER FX; DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC

Catalog Number	SPD2-US-040-320
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the customer provided a cine image from the procedure.A review of the cine was unable to identify the components of the spider fx or hawkone with certainty.Marker bands possibly from the hawkone were identified within the vessel but could not verify the tip was detached.The spider fx capture wire was included with the hawkone device which was connected to a cutter driver.The spider fx capture wire was inspected.The fractured off segment of the distal assembly from the hawkone was loaded onto the capture wire.The filter was located at the distal tip of the rotating tip of the hawkone.Biological debris was noted within the filter of the spider fx.No damage to the coiled tip was noted of the spider fx.It was discovered capture wire was loaded in the rotating tip of the hawkone.The capture wire outside of the proximal end of the guidewire tubing was curved and the ptfe was seen to worn away.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 terumo 6f sheath and spider fx, to treat a moderately calcified lesion with 80% stenosis in the superficial femoral artery as per ifu.Artery diameter 6mm, lesion length 200mm.It was reported difficulties were encountered advancing the device through a heavy calcium in the mid sfa, during removal the nosecone detached.The physician attempted to snare the nosecone but was unsuccessful.A cutdown was needed on the left iliac to remove the nosecone, an endarterectomy was performed, and stents were implanted.No allegation against spider fx.

• Brand Name: SPIDER FX
• Common Device Name: DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8090105
• Report Number: 2183870-2018-00515
• Device Sequence Number: 11102384
• Product Code: NFA
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K063785
• 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
• Report Date (Section B): 11/20/2018

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: 09/06/2020
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: A704162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/20/2018
• 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
• Patient Age: 82 YR
• Patient Weight: 88