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

Model Number	414-151
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable.Device lot number, expiration date unavailable.Device manufacture date unavailable.(b)(4).
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly calcific, fibrous lesion in the distal anterior tibial artery using a contralateral approach.A spectranetics turbo elite laser atherectomy catheter was chosen to treat the patient.According to the report, resistance was encountered when advancing the turbo elite device.However, the device was still advanced to the lesion site and treatment was given to the patient, with two passes of the laser fiber through the lesion.When the turbo elite device was removed from the patient, it was noted that the device was kinked and laser fibers could be seen in the kinked area.The procedure was completed with no reported patient harm.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.The device was discarded so it cannot be determined what caused the reported failure.
Additional Manufacturer Narrative
H3): the device was discarded, thus no investigation could be completed.H6): added codes: 772, 814, and 2199.In the initial mdr, section h11, it stated the above codes would be added upon availability to enter them into an updated medwatch form.The updated form was available 06 june 2021.This supplemental report was inadvertently not entered until this time; however, this supplemental report does not change the content nor does it provide new information to the event.The supplemental report is being submitted in order to enter the component and heic codes into appropriate fields within the updated supplemental medwatch form.

• 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: 11877489
• Report Number: 1721279-2021-00095
• Device Sequence Number: 1099897
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: 00813132024710
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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: 6F INTRODUCER SHEATH MANUFACTURER UNKNOWN; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other