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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 Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative
Patient information was requested from the site, but was not provided. The device was discarded by the site. Therefore, no evaluation will be performed.
 
Event Description
A philips representative reported that during a peripheral laser atherectomy procedure the radiopaque tip of the turbo-elite laser atherectomy catheter 420-159 separated from the device. The physician reported it was left in the profunda of the superficial femoral artery.
 
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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 Key8062306
MDR Text Key126897506
Report Number1721279-2018-00162
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K180694
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 01/01/2005,10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/10/2020
Device Model Number420-159
Device Catalogue Number420-159
Device Lot NumberFBH18H06A
Was Device Available for Evaluation? No
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 Received10/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2018
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: 11/12/2018 Patient Sequence Number: 1
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