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

Model Number	420-159
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth, age unk.Patient's gender unk.Patient's weight unk.Patient's ethnicity/race unk.Other relevant history unk.The device was not returned, thus no investigation could be completed.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a moderately calcified lesion in the patient's distal anterior tibial (at) vessel.The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.During use in the procedure, it was reported the tip of the catheter and the sheath appeared burned.A new turbo elite of the same model was used to complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Event or Problem Description
This event is no longer reportable for unintended radiation exposure - potential for harm.Per the returned device analysis, no broken fibers or breach to the outer jacket were observed.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 17 may 2022.G3): the device evaluation and investigation were completed on 19 may 2022.H3): the device was returned and evaluated by a cross functional team.Wrinkles on the outer jacket were observed just proximal and distal to the guidewire port as well as 3 cm and 7 cm from the distal tip.A substance, identified as an adhesive (such as rhoplex and covinax), was present on the device''s outer jacket, 15 cm from the distal tip.This adhesive is not used during the production process of the turbo elite catheter, indicating the adhesive substance came in contact with the catheter after distribution.Further research indicates the substance is common in adhesive tapes and medical applications.There were no breaches to the outer jacket, evidence of burn, or broken fibers on the turbo elite device.H6): hecc code corrected to 4582 (from 4565 on the initial mdr).Investigation conclusions code 67 remains appropriate for this event.The reported complaint could not be confirmed.There is no unintended radiation exposure; the event is no longer reportable.

• 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
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14366167
• Report Number: 1721279-2022-00092
• Device Sequence Number: 17587978
• Product Code: MCW
• UDI-Device Identifier: 00813132024727
• UDI-Public: (01)00813132024727(17)231117(10)FBF21L03A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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 Expiration Date: 11/17/2023
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBF21L03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 GUIDE WIRE MANUFACTURER UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Sex: Unknown