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

Catalog Number SPD2-US-050-320

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician intended to use spider fx in the distal common carotid artery to treat a severely tortuous plaque lesion.The device was prepped as per ifu.It was reported that when the physician was advancing the filter it deployed before it reached the marker on the tip of the catheter.The catheter was not stuck on the guidewire but the catheter was reported to have broken.A stent was used to pin the free floating catheter (detached tip) to the vessel wall which was distal to the stenosis.The physician used a pta device on the original area of interest (bifurcation of the iac and eac) and then aborted the procedure.The procedure was completed with just an.014 wire, unprotected.

Manufacturer Narrative

Device evaluation: the spiderfx filter and capture wire were received loaded in the green delivery end of the double ended catheter.It was noted that the white distal tip and green delivery catheter distal radiopaque marker band were missing on the returned double ended catheter.It was noted that the distal tip of the spiderfx distal assembly, (e.G.Floppy distal tip, coil, and filter), did not exhibit any damage associated with being advanced against resistance, (e.G.Kinking/bending).The fracture face on the distal end of the green delivery catheter appears to be a tensile fracture.The spiderfx filter was able to be loaded and unloaded with ease in the delivery catheter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8416766
• MDR Text Key: 138673133
• Report Number: 2183870-2019-00124
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068342
• UDI-Public: 00821684068342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Catalogue Number: SPD2-US-050-320
• Device Lot Number: A741523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention