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

Device Problems Deformation Due to Compressive Stress (2889); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

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 spider fx embolic protection device during treatment of a plaque lesion located in the patient¿s proximal, mid, and distal right superficial femoral artery (sfa) and popliteal artery (pa).Moderate vessel tortuosity and slight calcification are reported.Lesion exhibited 80% stenosis.Ifu was followed.The guidewire was hydrated during preparation.Vessel pre-dilation was not preformed.It is reported the hawkone was used over the spider fx device.The device was advanced over the bifurcation.The spider wire is reported to have prolapsed during the procedure.When the physician attempted to advance the hawkone device, the distal end of the rapid exchange port at the tip is reported to have torn.Tip damage is reported, and the guidewire lumen was torn form the distal tip.It was reported that the rapid exchange port along the stationary part of the nosecone came off the spider wire within the patient.The guidewire is not reported to have locked up on the catheter.The hawkone device and spider fx were removed successfully with no intervention required.There was no vessel damage noted.The devices were replaced with another spider fx and hawkone device 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 ; IE ; 091708734
• MDR Report Key: 10618436
• MDR Text Key: 209611981
• Report Number: 2183870-2020-00314
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• 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: 73 YR
• Patient Weight: 95