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

Catalog Number SPD2-050-320

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

The spider fx was inspected and observed the delivery catheter was cut.The approximate length of the deliver catheter from the distal end to the clear segment was 20.5 cm.The capture wire loaded the delivery catheter was advanced and observed the capture was filter assembly was missing.The capture wire and delivery catheter appeared to be cut by a sharp instrument.The length of the gold segment of the capture wire was approximately 182cm.The distal segment of the capture wire which included the filter assembly inspected.The approximate length of the segment was 8 cm.Image review one image of the spiderfx device was received from the customer.The image shows the proximal radiopaque section was within the green dual ended delivery catheter.The filter was observed outside of the green dual ended delivery catheter.The image shows the spider fx filter showed no damages or anomalies that would appear to have contributed to the reported experience.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a spider fx with a non-medtronic 8fr sheath during treatment of a 20mm plaque lesion in the patient¿s distal left common carotid artery of dimeter 4mm.Severe tortuosity and moderate calcification are reported.Lesion exhibited 90% stenosis.Ifu was followed, device prepped without issue.A non-medtronic guidewire was used it is reported that damage to the delivery was noted during advancement of the filter.Severe resistance was experienced when trying to pass the lesion.The filter was unable to be released after reaching the lesion site.The device was removed from the patient.Procedure was completed using a new spider fx.Following removal of the defective device from the patient, the tip of the delivery sheath was deformed, and the tip of the delivery sheath was cut off, and the spider was released in vitro to find the deformation of the spider.When the device was received for evaluation, it was noted that the device was damaged.

• 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: 9127636
• MDR Text Key: 194828294
• Report Number: 2183870-2019-00466
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Catalogue Number: SPD2-050-320
• Device Lot Number: A748435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Date Manufacturer Received: 09/18/2019
• Date Device Manufactured: 12/03/2018
• 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 Age: 72 YR