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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 06/03/2020
Event Type  Injury  
Manufacturer Narrative
Patient information unavailable.
 
Event Description
A peripheral procedure commenced on (b)(6) 2020 to treat a severely calcified lesion in the mid superficial femoral artery (sfa). This procedure was part of a postmarket study taking place in (b)(6), and a philips representative became aware of the event on 01 dec 2020. The physician chose to use a spectranetics turbo-tandem laser atherectomy catheter to treat the lesion. It was reported that after use of the turbo-tandem device, a dissection (grade a) was observed. A plain old balloon angioplasty (poba) (non-drug coated) was used to treat the dissection, the procedure was completed, and the patient survived the procedure. There was no alleged malfunction of the turbo-tandem device in use during the procedure. This report is being conservatively submitted because it cannot be confirmed at this time whether the turbo-tandem device was being used in the area in which the dissection was observed.
 
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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 Key11055535
MDR Text Key224245041
Report Number1721279-2020-00263
Device Sequence Number1
Product Code MCW
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
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: 12/22/2020 Patient Sequence Number: 1
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