MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ARTHERECTOMY CATHETER; TURBO ELITE

Model Number 420-006

Device Problem Crack (1135)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Dob/age unavailable, sex unavailable, weight unavailable, ethnicity unavailable, relevant testing unavailable, other relevant history unavailable, serial# unavailable.Manufacture has requested further information multiple times with no follow up received from company representative, health professional or user facility.

Event Description

A peripheral atherectomy procedure commenced using a spectranetics turbo elite device.Procedure indication is unavailable from the facility.During use of the turbo elite device the physician reported that the device had a small crack in the devices working length.The physician also noticed a red light coming out of the device where that crack in the device was located.A new turbo elite was used to complete the laser atherectomy without any further issues.The patient was successfully treated without any reported injury.This event is being reported due to the potential for exposure to manufacture materials and inadvertent laser energy/radiation exposure.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ARTHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sarah brevig ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9869341
• MDR Text Key: 227201207
• Report Number: 1721279-2020-00056
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)211011(10)FDA19K10A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140775
• 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: 01/01/2005,02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FDA19K10A
• Was Device Available for Evaluation?: No
• 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
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• 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