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U.S. Department of Health and Human Services

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

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ARTHERECTOMY CATHETER TURBO ELITE Back to Search Results
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.
 
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Brand NameSPECTRANETICS TURBO ELITE LASER ARTHERECTOMY CATHETER
Type of DeviceTURBO 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 Key9869341
MDR Text Key227201207
Report Number1721279-2020-00056
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K140775
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/11/2021
Device Model Number420-006
Device Catalogue Number420-006
Device Lot NumberFDA19K10A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received02/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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