MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 410-154

Device Problems Hole In Material (1293); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 04/19/2018

Event Type  malfunction  

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7507120
• Report Number: 1721279-2018-00057
• Device Sequence Number: 1
• Product Code: MCW
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/27/2019
• Device Model Number: 410-154
• Device Catalogue Number: 410-154
• Device Lot Number: FBE17M14B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Other