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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER

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SPECTRANETICS SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER Back to Search Results
Model Number 410-152
Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the manufacturer for evaluation. Visual investigation of the device found heavy damage to the device tip. The epoxy cap had been heavily damaged. A combination of patient tissue and epoxy was present at the tip of the device. The distal marker band was found to be present and attached, although it was buried within the material at the tip of the device. This damage is attributed to the overuse of the device.
 
Event Description
It was reported that during a peripheral vascular intervention procedure, the tip of the turbo elite device became loose. Reportedly, the physician was lasing an isr lesion within a viabahn stent. The first pass was completed at a fluence/pulse setting of 45/45, then was increased to 80/80 for the second pass. During the second pass, it was identified that the distal marker band was becoming or had become disconnected. The pass was completed and the device was removed with the marker band still attached. The case was then completed with pta and dcb. The patient was not affected.
 
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Brand NameSPECTRANETICS TURBO ELITE LASER ABLATION CATHETER
Type of DeviceTURBO ELITE
Manufacturer (Section D)
SPECTRANETICS
9965 federal drive
colorado springs CO 80921
Manufacturer (Section G)
SPECTRANETICS
Manufacturer Contact
nick mcnabb
9965 federal drive
colorado springs, CO 80921
719447-257
MDR Report Key6916989
MDR Text Key90029917
Report Number1721279-2017-00216
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
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
Type of Report Initial
Report Date 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/09/2019
Device Model Number410-152
Device Catalogue Number410-152
Device Lot NumberFBD17H04A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2017
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: 10/05/2017 Patient Sequence Number: 1
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