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

Catalog Number	SPD2-US-030-320
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician was using a spider fx embolic protection device while treating a moderately tortuous and moderately calcified mid left coronary artery lesion exhibiting chronic total occlusion.The vessel was not pre-dilated.A non-mdt guidewire was used.The ifu was followed during the procedure.It was reported that once the filter was positioned, the physician was unable to open the blockage.It was reported that when the physician attempted to recapture the filter, the tip detached.The detached tip was left in the patient.The physician commented that the tip would lodge in the branch.The surgery was turned down.No other patient injury was reported.
Additional Manufacturer Narrative
Additional information received: it was reported that the patient expired one week post procedure on (b)(6) 2017.V-fib after mi was the reported cause of death.It was reported that the death was not device related.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: 7127744
• Report Number: 2183870-2017-00594
• Device Sequence Number: 1210700
• Product Code: NTE
• UDI-Device Identifier: 00821684068304
• UDI-Public: 00821684068304
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 05/10/2018
• Device Catalogue Number: SPD2-US-030-320
• Device Lot Number: A274815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/18/2018
• 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: Other
• Patient Weight: 102