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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 TURBO ELITE

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER TURBO ELITE Back to Search Results
Model Number 410-152
Device Problem Material Perforation (2205)
Patient Problems Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Event Date 09/05/2019
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the facility. The device was evaluated 26sep2019 by cross-functional team. A breach in the catheter jacket was observed 21. 5 inches distal from the bifurcate. Broken laser fibers were confirmed. The jacket looked to be slightly twisted or kinked. Looking at the distal tip, broken and burned fibers were visible as well as fiber and epoxy erosion. Unable to determine the cause of the breach.
 
Event Description
A peripheral atherectomy procedure commenced to treat a fibrous lesion in the posterior tibial vessel. A spectranetics turbo-elite laser atherectomy catheter was utilized in the patient. It was found that the turbo-elite had a hole in the side of catheter, the laser fibers were exposed. A second turbo-elite was used to complete the procedure. No patient injury occurred. 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
catherine eaton
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key9131735
MDR Text Key160557128
Report Number1721279-2019-00165
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 01/01/2005,09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/10/2021
Device Model Number410-152
Device Catalogue Number410-152
Device Lot NumberFBD19G03A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
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 Received09/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2019
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: 09/27/2019 Patient Sequence Number: 1
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