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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 414-151
Device Problem Nonstandard Device (1420)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the facility. Visual and microscopic evaluation of the suspect device found a fiber sticking out of the bifurcate, not broken out of jacket. Appears to have occurred during manufacturing process. Fiber is active. No other damage to the rest of the catheter detected.
 
Event Description
A philips representative reported that during preoperation for a peripheral atherectomy procedure, the integrity of the turbo-elite atherectomy 414-151 catheter was questioned. The device was removed from the procedure and a second turbo-elite atherectomy 414-151 catheter was used instead. Procedure completed successfully, with no harm to the patient or user. The device was returned to the manufacturer for evaluation and it was determined on 30-nov-2018, that the catheter had exposed laser fibers outside of the catheter sheath. 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 Key8201178
MDR Text Key131626410
Report Number1721279-2018-00181
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 01/01/2005,11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/13/2020
Device Model Number414-151
Device Catalogue Number414-151
Device Lot NumberFAY18J07A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
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 Received01/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2018
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: 12/27/2018 Patient Sequence Number: 1
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