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

Model Number SPD2-US-060-320

Device Problems Peeled/Delaminated (1454); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation visual inspection: an inspection of the spider fx showed no damages or anomalies to the filter assembly or green distal segment of the capture wire.An inspection of the black proximal segment of the capture wire showed the areas of the wire where ptfe was not present.Areas of the exposed wire were noted at the following areas measured from the proximal tip of the capture wire: 11-13cm, 21-33cm, and 35-38cm.Under microscope the areas of compromised ptfe are longitudinal and is not present around the circumference of the wire.An area of the exposed wire shows the pft curved outward and then back proximally at a distal edge of the observed damage and string-like debris was observed.It is possible the debris may be fibrous from an external source used to wipe the capture wire.The pffe shows characteristics consistent with exposure to friction, possibly scraped.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a spider fx embolic protection during procedure.It was reported that, during the procedure, as the surface coating of the spider wire was peeled off, there was a defect of sedimentation of coating foreign matter in the catheter and wire kinking.It is unknown if the spider wire was exposed when the hydrophilic coating peel was noted.The device was removed safely and the procedure was completed with a new medtronic device.There was no patient injury reported.When the device was returned to the manufacturing facility, it was noted confirmed the coating was peeled.

• 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 ; IE ; 091708734
• MDR Report Key: 10545249
• MDR Text Key: 207308059
• Report Number: 2183870-2020-00296
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068366
• UDI-Public: 00821684068366
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 09/17/2020

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: 11/11/2021
• Device Model Number: SPD2-US-060-320
• Device Catalogue Number: SPD2-US-060-320
• Device Lot Number: A930619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• 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