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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 420-006
Device Problem Temperature Problem (3022)
Patient Problems Burning Sensation (2146); Radiation Exposure, Unintended (3164)
Event Date 11/07/2019
Event Type  malfunction  
Manufacturer Narrative
The physician in this procedure was male. Patient information not obtained for this event; there is no reported patient harm.
 
Event Description
A peripheral vascular intervention commenced to treat a lesion in the patient's superficial femoral artery (sfa). During use of the spectranetics turbo elite device, it was reported that the physician felt a sensation which felt warm through his glove. He expressed discomfort in his finger. The location of this occurrence was reportedly where the physician's fingers were placed while the device was in use, outside of the patient's body. It was believed that the physician's glove remained intact, and it was reported that no first aid or intervention was required for this area on the physician's finger. The procedure was completed with the device and the patient survived the procedure. In addition, due to the description of the event reported to the manufacturer, this event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation, in the event that the device was broken. The manufacturer is anticipating the return of the device for evaluation but has not yet arrived at the manufacturer.
 
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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 Key9366094
MDR Text Key194398914
Report Number1721279-2019-00207
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
Report Date 01/01/2005,11/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/18/2021
Device Model Number420-006
Device Catalogue Number420-006
Device Lot NumberFBA19G16A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
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 Received12/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2019
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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