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

Catalog Number SPD2-060-320

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the spiderfx device was returned within its shelf box, sterile pouch and transportation hoop.No ancillary devices, cine, images or procedure notes were returned for evaluation.The device was removed from the hoop for analysis.Visual inspection of the catheter shaft reveal no physical damage (kink, twist).No abnormality was noted on the catheter distal tip and capture wire.The filter was observed within a clear segment.A 0.014in guidewire from analysis lab was loaded successfully through the green dual delivery catheter.The guidewire would advance and exit the rx exit port with no resistance noted.When the capture wire was attempted to advance the filter out of the clear segment , it was met with resistance and the filter would not advance.The catheter was soaked in for 3hrs in ultrasonic bath.Post soaking, it was observed the flex connector was detached within the filter basket.The damage observe d is consistent with resistance encountered during advancement.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a spider fx during procedure to treat a little calcified plaque lesion in the left mid internal carotid artery with 60% stenosis.The vessel diameter and lesion length are 5mm and 30mm respectively.The vessel was no pre or post dilated.Ifu was followed.It was reported that the device was unable to cross the lesion.Physician used another manufacturer's device to complete the procedure.There was no patient injury reported.

• 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 ; EI ; 091708734
• MDR Report Key: 10860496
• MDR Text Key: 216915596
• Report Number: 2183870-2020-00392
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K063204
• 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
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Catalogue Number: SPD2-060-320
• Device Lot Number: A786430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2019
• 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: 65 YR
• Patient Weight: 58