MAUDE Adverse Event Report: MEDTRONIC, INC. SPIDER FX; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number SPD2-US-060-320

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/13/2018

Event Type  Injury  

Event Description

A filter was used during a peripheral interventional procedure to prevent emboli in limb.When attempting to remove filter, it would not collapse enough to remove through sheath.Because of the tension on the filter while trying to remove it, the filter wire broke, leaving the filter in the iliac artery.Additional intervention, including placing a stent over the filter to trap it, was performed.This ultimately left the filter inside the patient.

• Brand Name: SPIDER FX
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): MEDTRONIC, INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7472367
• MDR Text Key: 106881572
• Report Number: 7472367
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/25/2019
• Device Model Number: SPD2-US-060-320
• Device Catalogue Number: SPD2-US-060-320
• Device Lot Number: A528947
• Other Device ID Number: EMBOLIC PROTECTION DEVICE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 83