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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

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SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER Back to Search Results
Model Number 410-152
Device Problems Material Frayed (1262); Difficult to Advance (2920)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 04/05/2017
Event Type  malfunction  
Manufacturer Narrative
Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluation: distal to the luer 11. 5 inches, the outer jacket is broken with exposed fibers.
 
Event Description
Vascular intervention procedure in an anterior tibial artery due to severe calcification. The catheter jacket frayed as the physician was trying to advance the laser fiber. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation. The procedure was completed by other means, and the patient was discharged per operative plan.
 
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Brand NameSPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
Type of DeviceTURBO ELITE
Manufacturer (Section D)
SPECTRANETICS
9965 federal drive
colorado springs CO 80921
Manufacturer (Section G)
SPECTRANETICS
Manufacturer Contact
barbara creel
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key6527540
MDR Text Key207100965
Report Number1721279-2017-00073
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,04/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2019
Device Model Number410-152
Device Catalogue Number410-152
Device Lot NumberFBD17C14A015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
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 Received07/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/27/2017 Patient Sequence Number: 1
Treatment
SPECTRANETICS CVX-300 EXCIMER LASER
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