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

Catalog Number	SPD2-US-050-190
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the spiderfx embolic protection device was received for evaluation.Not all components of the delivery catheter were returned for evaluation.No ancillary devices or cine images from the procedure were received.The spiderfx filter was received pulled fully proximally into the transparent section of the delivery catheter end of the duel ended catheter.The delivery catheter was separated at the primary wire exit port.The delivery catheter separation face exhibited torsional and tensile stretching.The portion of the delivery catheter distal of the primary wire exit port was not returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was that the physician used a spider fx device during treatment of a cto (chronic total occlusion-100%) plaque lesion in the patient¿s proximal common carotid artery.No tortuosity and moderate calcification were reported.The ifu was followed during the procedure.The device was prepped without issue.The vessel was pre-dilated.It was reported that the delivery catheter broke and segments had to be retrieved.A snare was used to retrieve the fragments from the patient.The procedure was then completed without the use of embolic protection.The vessel was post dilated.No patient injury was reported.

• 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: 7587179
• Report Number: 2183870-2018-00328
• Device Sequence Number: 1530055
• Product Code: NTE
• UDI-Device Identifier: 00821684068335
• UDI-Public: 00821684068335
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/11/2018

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: 11/09/2018
• Device Catalogue Number: SPD2-US-050-190
• Device Lot Number: A373195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/11/2018
• 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