• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER Back to Search Results
Model Number 420-006
Device Problems Break (1069); Difficult to Advance (2920)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 10/23/2017
Event Type  Injury  
Manufacturer Narrative
Patient information unavailable. Device evaluation: a visual inspection of the catheter was performed with no bend to the catheter. There was a breach seen to the jacket ~1/4inch from the tip of the catheter.
 
Event Description
During a patient procedure, the physician had difficulty advancing the laser catheter through a sheath. It was reported that the tip of the laser catheter looked and felt bent when the catheter was being loaded onto the wire. The device was removed and the procedure was successfully completed with another laser catheter with no reported patient harm. Upon device evaluation, a breach in the jacket discovered. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
Type of DeviceTURBO ELITE
Manufacturer (Section D)
SPECTRANETICS
9965 federal drive
colorado springs CO 80921
Manufacturer (Section G)
SPECTRANETICS
Manufacturer Contact
barbara creel
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key7118244
MDR Text Key94882708
Report Number1721279-2017-00291
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 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/23/2019
Device Model Number420-006
Device Catalogue Number420-006
Device Lot NumberFBA17H17A378
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
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: 12/14/2017 Patient Sequence Number: 1
Treatment
SPECTRANETICS CVX-300 EXCIMER LASER
-
-