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

Model Number	417-152
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is anticipating the return of the device for evaluation but has not received it at this time.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly fibrous lesion in the mid peroneal artery using a contralateral approach.The physician chose to use a spectranetics turbo elite laser atherectomy catheter.It was reported that during pullback, with the turbo elite device lasing, the device's distal radiopaque marker band detached from the device within the patient.It was reported that the physician was not lasing in the presence of contrast medium, and the device was flushed per the spectranetics instructions for use (ifu).The physician used a medtronic balloon to successfully remove the marker band from the patient.The procedure was completed with no reported patient harm.The manufacturer is anticipating return of the turbo elite device for evaluation, but has not yet received it.
Additional Manufacturer Narrative
D10): device was returned to the manufacturer on 09 mar 2021.H3): device was evaluated by manufacturer; device evaluation in narrative below.H6): method, results and conclusions codes populated within their respective sections now that device has been evaluated.H6): correction: in addition, this supplemental report is to clarify that the mdr submitted is not the subject of an approved exemption and therefore number ¿5645646¿ included in the ¿exemption number¿ field was submitted in error.This exemption number has now been removed.Device evaluation: the device was returned and investigated by a cross functional team on 11 march 2021.The team determined the cause of the event was due to due a circumferential void located at the locking feature of the device's distal band.This void prevented the epoxy from locking the distal marker band into place which allowed the band to become detached during the procedure.The was no additional damage identified to the device.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11416346
• Report Number: 1721279-2021-00026
• Device Sequence Number: 3382383
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)221215(10)FAZ20L18A
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Exemption Number: 5645646
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ20L18A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT 0.014 GUIDE WIRE; MEDTRONIC BALLOON; SPECTRANETICS CVX-300 EXCIMER LASER; TERUMO 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention