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U.S. Department of Health and Human Services

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

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER Back to Search Results
Model Number 410-152
Device Problems Crack (1135); Fracture (1260); Deformation Due to Compressive Stress (2889)
Patient Problems Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
Patient weight unavailable.
 
Event Description
A peripheral vascular intervention procedure commenced to treat a chronic total occlusion (cto) in the patient's right anterior tibial (at) artery. During the procedure, the rep reported the spectranetics turbo elite could not cross the calcified lesion. When the device was removed from the patient, it was reported that the device's working length ''buckled'' and cracked the device's outer jacket, near where the physician was holding onto the device. A second device was used to complete the procedure. No user or patient harm was reported. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
 
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Brand NameSPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
Type of DeviceTURBO 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 Key9267998
MDR Text Key196640181
Report Number1721279-2019-00191
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,user f
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/05/2021
Device Model Number410-152
Device Catalogue Number410-152
Device Lot NumberFBD19G31A
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 Received10/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
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: 11/01/2019 Patient Sequence Number: 1
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