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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER Back to Search Results
Model Number 417-152
Device Problems Device Operates Differently Than Expected (2913); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2018
Event Type  malfunction  
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Brand Name
SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
Type of Device
TURBO ELITE
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 Key7519084
Report Number1721279-2018-00060
Device Sequence Number1
Product Code MCW
Reporter Country CodeUS
PMA/PMN Number
K170059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/01/2005,04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date11/22/2019
Device Model Number417-152
Device Catalogue Number417-152
Device Lot NumberFAZ17L17B012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number0
Treatment
SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS TURBO-POWER ATHERECTOMY CATHETER
Patient Outcome(s) Required Intervention;
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