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

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis the spider fx was received loaded inside a 0.035" x 135cm support catheter.Four sections of folded over wet gauze was included.No other ancillary devices were included.The wet gauze was opened.Traces of excised tissue and possibly ptfe from the spider fx capture wire were observed.Other pieces of the wet gauze showed blue piece plastic in nature approximately 1cm long included.A metallic coiled strip of material was included once of the pieces of gauze.The piece was approximately 1.5cm long.The spider fx capture wire was exposed outside the support catheter approximately 50cm.The exposed filter assembly showed no damages or anomalies.Biological debris was observed with the filter basket.The capture wire was inspected and found portions of the ptfe was scraped off longitudinally.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a hawkone atherectomy device with a non-medtronic 6fr sheath and spider fx embolic protection device during treatment of a 150mm, fibrous and soft tissue cto (chronic total occlusion-100%) in the patient¿s mid and distal superficial femoral artery (sfa).Slight vessel calcification and tortuosity are reported.Artery diameter reported as 6mm.Ifu was followed.Vessel pre-dilation was not performed.There was no damage noted to the spider fx during prep.The spider fx was properly flushed prior to use.Ancillary device interaction is reported.It is reported that the hawkone device was unable to pack.During cleaning foreign material was noted.The metallic threads were noted upon cleaning.Both devices were safely removed from the patient.The device was replaced to complete the procedure.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: 11169282
• MDR Text Key: 226765860
• Report Number: 2183870-2021-00020
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111010
• 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
• Report Date: 01/14/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/14/2021
• 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: 80 YR
• Patient Weight: 107