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

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY

  • 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
 

THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 423-001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)
Event Date 03/16/2021
Event Type  Injury  
Manufacturer Narrative
Patient's date of birth unavailable. Patient''s ethnicity/race unavailable. Relevant tests/laboratory data unavailable. The device was discarded, thus no investigation could be completed.
 
Event Description
A philips (b)(6) representative became aware on 01 june 2021 that a peripheral atherectomy procedure commenced on (b)(6) 2021 to treat an in-stent occlusion in the proximal, mid and distal region of the superficial femoral artery (sfa) in the patient''s left lower extremity. This event was part of a postmarket study occurring in japan. The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient. It was reported that lesion was present in the vessel proximal and distal to the stent, as well as being present in the stent itself. It was reported that the turbo elite device successfully lased through the lesion, clearing the obstruction. However, it was reported that after the turbo elite device was used, an acute occlusion was confirmed on angiogram; the report stated that the blood vessels recoiled after applying the turbo elite device to the in-stent lesion. The obstructive lesion outside the stent had not been dilated at that time, and an influx of contrast medium was then present within the sfa, and no laser based blood flow was present on the angiogram image. A wire was then passed through to the occlusion reportedly outside the blood vessel, and the patient was treated with a non-drug coated balloon catheter. However, a grade c dissection was confirmed on angiogram after use of the balloon catheter. There was no avoidant treatment performed after the dissection. The procedure was completed and the patient survived. The physician did not know what caused the dissection. The patient was discharged without further incident on (b)(6) 2021. This report is being submitted to capture the turbo elite device and an acute occlusion was confirmed, after the device''s use, within the sfa. There was no alleged malfunction of the turbo elite device used during the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer (Section G)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer Contact
barbara creel
9965 federal drive
colorado springs, CO 80921
MDR Report Key12096044
MDR Text Key265176705
Report Number1721279-2021-00119
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K170059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/26/2021
Device Model Number423-001
Device Catalogue Number423-001
Device Lot NumberFBC19L19A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2019
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: 06/30/2021 Patient Sequence Number: 1
-
-