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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 420-006
Device Problems Radiation Leak (1357); Material Perforation (2205)
Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685); Radiation Exposure, Unintended (3164)
Event Date 10/11/2018
Event Type  Injury  
Manufacturer Narrative
Patient information is physician's information as it was the physician that was burned, not the patient. Physician's age and weight were not provided. Although return has been requested, the suspect device has not been received by the manufacturer for evaluation.
 
Event Description
A philips vascular intervention representative reported that during a peripheral atherectomy procedure, the spectranetics turbo-elite atherectomy laser catheter 420-006 got hot and burned through the physician's gloves, burning his right hand. He felt this occur as he advanced the catheter after the last pass (2nd pass). The only intervention needed was changing his gloves (as the catheter had burned through them) and running his hand under cold water. This issue did not affect his ability to finish the procedure or perform any others. It was reported that a breach was seen in the catheter jacket. 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 Key8043943
MDR Text Key126354735
Report Number1721279-2018-00156
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 01/01/2005,10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2020
Device Model Number420-006
Device Catalogue Number420-006
Device Lot NumberFBA18G23A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2018
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 Received02/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2018
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: 11/06/2018 Patient Sequence Number: 1
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