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

Model Number	SPD2-US-040-320
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The physician used the spider fx during a procedure to treat the popliteal artery as per ifu.It was reported when attempting to recapture the filter wire, the filter became detached from the wire.A gooseneck snare was used to snare the filter and pull it back into the sheath.All the devices were removed from the patient as a unit.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: only the distal assembly of the spider fx embolic protection system was received for evaluation.No ancillary devices or cine images from the procedure were received.The capture wire appears to have separated between the filter¿s proximal marker band and the proximal end of the filter¿s flex connector.The capture wire proximal to the flex connector appears to have two sharp bends.The separation face of the capture appears to be from a kink.The bends and kink indicate that the capture wire was prolapsed within the mouth of the filter when the separation happened.The floppy distal tip wire has an ¿s¿ bend.All components of the floppy distal tip are accounted for.All the components of the distal assembly are accounted for.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6445554
• Report Number: 2183870-2017-00152
• Device Sequence Number: 1042125
• Product Code: NFA
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2017

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: 10/21/2017
• Device Model Number: SPD2-US-040-320
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: A177125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided; 05/25/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 06/23/2017; 10/02/2017
• 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