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U.S. Department of Health and Human Services

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

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-TANDEM LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 472-110
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Iatrogenic Source (2498); Vascular Dissection (3160)
Event Date 06/23/2020
Event Type  Injury  
Manufacturer Narrative
Patient's date of birth unavailable.
 
Event Description
A philips representative became aware on 17 nov 2020 that a peripheral atherectomy commenced on (b)(6) to treat a patient (indication for procedure or other case information unavailable). This procedure was part of a postmarket study occurring in (b)(6). From the report, a spectranetics turbo-tandem laser atherectomy catheter was in use. After use of the turbo-tandem device, an arterial dissection was observed on angiography. A plain old balloon angioplasty (poba) was used to treat the dissection and another angioplasty was performed, which confirmed that nothing abnormal was detected after poba was completed. The procedure was completed, and the patient survived. There is no alleged malfunction of the turbo-tandem device used in the procedure.
 
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Brand NameSPECTRANETICS TURBO-TANDEM LASER ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer Contact
barbara creel
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key11134116
MDR Text Key231959032
Report Number1721279-2021-00005
Device Sequence Number1
Product Code MCW
UDI-Device Identifier00813132020248
UDI-Public(01)00813132020248(17)200803(10)FBY18G18A
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K094036
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 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/03/2020
Device Model Number472-110
Device Catalogue Number472-110
Device Lot NumberFBY18G18A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2018
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: 01/07/2021 Patient Sequence Number: 1
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