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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 CATHETER, PERIPHERAL, ATHERECTOMY

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 410-152
Device Problems Break (1069); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problem Unintended Radiation Exposure (4565)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
The device was discarded, thus no investigation could be completed. Because the device was not returned for evaluation, the cause of the reported damage could not be determined.
 
Event Description
A peripheral atherectomy procedure commenced to treat a lesion in the distal tibial artery. The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient. The report stated that the physician had pedal access to the lesion, as well as access from above. He advanced the turbo elite device from above while holding fairly aggressive back pressure as he attempted to cross the lesion. A few different settings on the turbo elite device were used to attempt to cross the lesion, but were unsuccessful. As the physician was trying to advance the laser, the outer jacket reportedly started to wrinkle and it seemed the device was having a hard time tracking, or possibly getting stuck on the wire, which was a 14 command wire. The philips representative advised the physician to stop and withdraw the turbo elite device from the patient. He was then able to cross the lesion via balloon angioplasty from the pedal access, and the procedure was completed with no reported patient harm. The physician stated he didn't believe the device was defective; he stated he was just being pretty rough with it. The philips representative stated that the catheter had wrinkles present, along with a tear in the device's outer jacket with exposed fibers. She was unsure if the device was also manipulated by the physician and/or tech after it was removed from the patient. This event is being reported due to unintended radiation exposure, potential for harm.
 
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Brand NameSPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer (Section G)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer Contact
barbara creel
9965 federal drive
colorado springs, CO 80921
MDR Report Key12217292
MDR Text Key263439671
Report Number1721279-2021-00137
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
Report Date 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number410-152
Device Catalogue Number410-152
Device Lot NumberFBD21D20A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2021
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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