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

Model Number	423-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth, age unk, patient gender unk, patient weight unk, patient's ethnicity/race unk, relevant tests/laboratory data unk, other relevant history unk, the device was not returned to the manufacturer, thus an investigation could not be completed.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly calcified lesion in the patient's mid popliteal artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During the procedure, the device's marker band detached and was successfully retrieved using a balloon.The procedure was completed with this device with no reported patient harm.This report captures the turbo elite device in use when its marker band detached within the patient, requiring intervention.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 26 apr 2022.G3): the device evaluation and investigation were completed on 24 may 2022.H3): the device was returned and evaluated by a cross functional team.The distal marker band was returned, detached from the distal end of the turbo elite.The turbo elite''s distal tip had a slight epoxy void.A white substance was observed within the epoxy void at the turbo elite''s distal tip; the substance was identified as sodium, which was not considered to be a reasonable root cause for the detachment of the marker band.Observing the marker band, the locking feature was seen all the way around the inner diameter (within specifications for the device).Measurements of the distal marker band were found to be within specifications.H6): based on the device evaluation and investigation, this failure is determined to be production process related.

• 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13361334
• Report Number: 1721279-2022-00018
• Device Sequence Number: 1675295
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)230730(10)FBC21G27A
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC21G27A
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: BALLOON MANUFACTURER AND SIZE UNK; BOSTON SCIENTIFIC 0.018 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 7F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown