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

Catalog Number SPD2-050-320

Device Problems Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported a spider fx device was used during patient treatment.Ifu was followed.Pre-dilation was performed.It is reported that a kink was observed during second advancement of the device resulting in the tip of the guide wire of the filter was discounted (detached) in the conveyor sheath.This was discovered during deployment of the filter.No patient injury reported.

Manufacturer Narrative

Additional information: target treatment vessel was patient¿s carotid artery.The device was removed and replaced to complete the procedure.The filter was bent in the delivery sheath.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the spider fx was removed from the box and inspected.It was observed the capture wire was loaded the delivery catheter.Approximately 0.6cm of the coiled tip of the filter assembly was exposed outside of the delivery catheter.A second wire was observed looped around was exposed from the distal tip of the catheter.The green delivery catheter was flattened/crushed at the distal marker band of the delivery catheter, proximal to the white radiopaque tip of the catheter.With direct lighting applied to the catheter, it was observed the filter was loaded within the distal end of the delivery catheter.The capture wire was attempted to be advanced and then retracted.The capture would not move within the delivery catheter.The coiled tip of the filter assembly which was exposed was pulled.The entire segment of the coiled tip exposed and found the observed second wire from the tip of the catheter was the tip wire of the filter assembly.The tip wire exhibited a curve which was approximately 180 degrees.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: 8309611
• MDR Text Key: 135512083
• Report Number: 2183870-2019-00058
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: SPD2-050-320
• Device Lot Number: A683300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 04/25/2019
• Supplement Dates FDA Received: 03/13/2019; 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2018
• 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