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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 420-159
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
Patient age, ethnicity and race are unavailable from the site. Device has been requested back, but has not yet been received by the manufacturer for evaluation.
 
Event Description
A (b)(6) representative reported that during a peripheral atherectomy procedure the superficial femoral artery (sfa) was 80% occluded with a plaque lesion. A femoral access was used for a contralateral approach to advance the turbo-elite laser atherectomy catheter 420-159 through the vessel. While lasing, the radio-opaque marker band came off the end of the turbo-elite catheter in the sfa. The physician was able to retrieve it with a 2. 0 minitrek coronary balloon. Delay of 1/2 hour occurred due to time needed for retrieval. No harm to the patient.
 
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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 Key8072259
MDR Text Key128477485
Report Number1721279-2018-00163
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 01/01/2005,10/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/17/2018
Device Model Number420-159
Device Catalogue Number420-159
Device Lot NumberFBH16L11A
Was Device Available for Evaluation? Yes
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 Received01/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2016
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: 11/14/2018 Patient Sequence Number: 1
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