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

Catalog Number SPD2-050-320

Device Problems Fracture (1260); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a spider fx embolic protection device with a 9fr25cm non-medtronic sheath and non-medtronic 0.014 guidewire during patient treatment.Ifu was followed.Moderate vessel tortuosity reported.The vessel is described as stenosed.Vessel pre-dilation was performed.It was reported that it was speculated that damage, a fracture, occurred during preparation.It is reported the filter ring part of spider fx had hangnail and had stood and there was strong resistance when pulling it into the dual-end catheter during priming.The physician proceeded to use this device during the procedure due to no other device being available.Moderate resistance is reported at the time of delivery.No component detachment occurred.The device was reported to not be used successfully due to it being used by force.It was noted that it was more difficult to remove the device compared to normal as resistance was strong.It is unknown if the device is intact upon removal as the hangnail issue was still present.It could not be found if there was vessel damage noted as there was no blood vessel damage on the fluoroscopy.Fluoroscopy could not confirm that there was no blood vessel damage as it could not be confirmed by angioscopy.It was not possible to know how much scuffing damage was done by the hangnail on t he blood vessel unless a check was done with a blood vessel endoscope.The carotid artery stenting (cas) procedure was performed.Post-dilation was performed.No patient injury reported.

• Brand Name: SPIDER FX
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12421306
• MDR Text Key: 282962170
• Report Number: 2183870-2021-00316
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/03/2021

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
• Device Expiration Date: 06/27/2023
• Device Catalogue Number: SPD2-050-320
• Device Lot Number: B226889
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1