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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 414-159
Device Problems Break (1069); Material Split, Cut or Torn (4008)
Patient Problem Unintended Radiation Exposure (4565)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
The device was discarded, thus no investigation could be completed.
 
Event Description
A peripheral atherectomy procedure commenced to treat a slightly calcified lesion in the patient's mid superficial femoral artery (sfa). The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient. After the physician used the turbo elite device in the patient and was removing the device, he noticed the "outer sheath was torn" and fibers were visible. It was reported that there was difficulty getting the turbo elite device through the sheath and believed that may have been the reason the device was damaged. A new spectranetics turbo elite laser atherectomy catheter was used to finish the procedure, and there was no reported patient harm. This event is being submitted to capture the turbo elite which was found damaged during use and resulted in unintended radiation exposure with 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
nicole worford
9965 federal drive
colorado springs, CO 80921
MDR Report Key12333209
MDR Text Key267063231
Report Number1721279-2021-00151
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 07/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number414-159
Device Catalogue Number414-159
Device Lot NumberFBF21B18A
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 Received07/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2021
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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