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

Catalog Number	SPD2-US-040-320
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the returned spider fx device was removed from the protective hoop and inspected.The capture wire was loaded within the delivery catheter with the distal coiled tip exposed outside of the distal end of the catheter.The filter was noted approximately 1.5 cm from the distal rim of the catheter and approximately 0.5cm of the coiled tip was exposed outside of the delivery catheter.The filter assembly was inspected under microscope and observed the coiled tip showed stretching between coils at the proximal end of the tip (approximately 1cm from the distal tip).No damage other damages or anomalies were observed to the filter assembly.The capture wire was not snapped at the snap location.The total length of the capture wire was approximately 320 cm.According to the product labeling for the spider fx associated to lot a320391 the length of the capture wire is 320cm.The delivery catheter was visually inspected and noted kinks to the catheter approximately 2.8 and 3.7cm from the distal tip.The spider fx capture wire was retracted back into the clear segment of the catheter with no resistance.The capture wire was advanced and was able to expose the filter assembly outside the distal tip of the delivery catheter with no resistance.
Event or Problem Description
Physician intended to use a spider fx embolic protection device during a procedure.It was reported that ifu was followed, but during the procedure the wire was broken.As the physician felt that the spider fx device could not be used, the device was replaced with another one to continue the procedure.No.No patient injury reported, and no intervention was required.
Additional Manufacturer Narrative
Additional information: confirmation received that the device was used in the patient.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: 6916557
• Report Number: 2183870-2017-00429
• Device Sequence Number: 13765830
• Product Code: NTE
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2017

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: 08/01/2018
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: A320391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/15/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1