MAUDE Adverse Event Report: EV3 INC. SPIDER FX. EMBOLIC PROTECTION DEVICE; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Catalog Number SPD2-US-070-320

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2016

Event Type  Injury  

Event Description

Peripheral intervention was being performed.While removing a full filter wire, the wire became lodged in the common femoral artery.The patient went emergently to the operating room for removal of the filter wire and atherectomy catheter.

• Brand Name: SPIDER FX. EMBOLIC PROTECTION DEVICE
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): EV3 INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 5513242
• MDR Text Key: 40735146
• Report Number: 5513242
• Device Sequence Number: 1
• Product Code: NFA
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SPD2-US-070-320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2016
• 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
• Treatment: JETSTREAM 2.4/3.4MM G3 - WAS THE ATHERECTOMY CATHE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 102