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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 423-001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 05/19/2021
Event Type  Injury  
Manufacturer Narrative
Patient's date of birth: unk. Relevant tests/laboratory data: unk. The device was discarded, thus no investigation could be completed.
 
Event Description
A peripheral atherectomy procedure commenced, included as part of a (b)(6) postmarket study. The procedure was an in-stent restenosis (isr) to treat a lesion in the patient's mid superficial femoral artery (sfa). The physician chose a spectranetics turbo elite laser atherectomy catheter and a drug coated balloon catheter to treat the patient. After the procedure, a grade b arterial dissection was observed after use of the turbo elite, and observed also after use of the balloon. There was no need for intervention. The procedure was completed successfully and the patient was discharged three days later with no further complications. This report captures the turbo elite device in use when the arterial dissection occurred, with no intervention required. There was no alleged malfunction of the turbo elite device in use during 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 (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 Key13022388
MDR Text Key285669329
Report Number1721279-2021-00251
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K170059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2022
Device Model Number423-001
Device Catalogue Number423-001
Device Lot NumberFBC20D15A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2020
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: 12/16/2021 Patient Sequence Number: 1
Treatment
DRUG COATED BALLOON MANUFACTURER AND MODEL UNK; GUIDE CATHETER MANUFACTURER AND SIZE UNK; GUIDE WIRE MANUFACTURER AND SIZE UNK; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
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