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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 CATHETER, PERIPHERAL, ATHERECTOMY

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 420-006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 01/18/2021
Event Type  Injury  
Manufacturer Narrative
Patient's date of birth unavailable. (b)(4).
 
Event Description
It was reported to philips (b)(6) on (b)(6) 2021 that a peripheral atherectomy procedure commenced on (b)(6) 2021 to treat a slightly calcified in stent occlusion of the patient''s superficial femoral artery (sfa). This event was reported as part of a postmarket study in (b)(6). The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the lesion, proximal to distal. According to the report, after the turbo elite device was used, an arterial non flow limiting dissection (grade c) was confirmed, outside of and proximal to the stent. A plain old balloon angioplasty (poba) was performed, but dissection was confirmed after poba as well. Afterward, it was reported "no particular bailout was performed". The procedure was completed, and the patient was discharged from the hospital on (b)(6) 2021 with no adverse event being reported. There was no alleged malfunction of the turbo elite device used in the procedure.
 
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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 Contact
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key11826323
MDR Text Key265548097
Report Number1721279-2021-00090
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K170059
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/23/2021
Device Model Number420-006
Device Catalogue Number420-006
Device Lot NumberFBA19M19B
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 Received06/06/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/19/2019
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: 05/14/2021 Patient Sequence Number: 1
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