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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 420-006
Device Problem Break (1069)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 09/23/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device was returned, and evaluated by a cross functional team on (b)(6) 2020. A breach in the device's outer jacket and broken/darkened fibers were observed at 86cm proximal of the device's distal tip. The device's inner lumen was intact, but slightly darkened. There was no other damage noted to the device. Historically, the manufacturer has seen this failure occur while the catheter is being manipulated. This manipulation causes the device's fibers to break. While using the laser with broken fibers, laser energy is then directed into the device's outer jacket in the location of the broken fibers, causing a breach to the outer jacket. This failure has been determined to be use related.
 
Event Description
It was reported on (b)(6) 2020 to a philips representative that a peripheral vascular procedure commenced on (b)(6) 2020 to treat a chronic total occlusion (cto) of the patient's mid superficial femoral artery. The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient. During the procedure, it was reported that the procedure was completed using the turbo elite device; however, it was also reported that the casing of the catheter was destroyed during use (no further detail was provided, and the philips representative reporting the event did not attend the procedure). Upon return of the device to the manufacturer and subsequent evaluation that took place on (b)(6) 2020, the team discovered a breach to the device's outer jacket, making it a reportable event due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation. The patient survived the procedure and there was no reported patient injury.
 
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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 Contact
barbara creel
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key10800968
MDR Text Key215502443
Report Number1721279-2020-00224
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 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/23/2022
Device Model Number420-006
Device Catalogue Number420-006
Device Lot NumberFBA20F15A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
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: 11/06/2020 Patient Sequence Number: 1
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