MAUDE Adverse Event Report: EV3 INC. TURBOHAWK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number THS-SS-C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/06/2016

Event Type  malfunction  

Event Description

Report indicates "malfunction of handle at turbohawk.".

• Brand Name: TURBOHAWK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): EV3 INC.; 4600 nathan ln north; plymouth MN 55442
• MDR Report Key: 5406410
• MDR Text Key: 37345849
• Report Number: 5406410
• Device Sequence Number: 1
• Product Code: MCW
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/11/2018
• Device Catalogue Number: THS-SS-C
• Device Lot Number: A171805
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2016
• 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
• Patient Age: 68 YR