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	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a moderately calcified plaque lesion in the patient's distal superficial femoral artery (sfa).The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.The device was previously used in the patient's common femoral artery (cfa) before use within the sfa.While the turbo elite device was treating the lesion within the sfa, the device's distal marker band detached within the patient vasculature.The marker was retrieved using a filter and a snare.Another turbo elite device was used to successfully complete the procedure.The patient survived with no reported harm.This report captures the turbo elite device in use when its marker band detached within the patient, requiring intervention.
Additional Manufacturer Narrative
Device evaluation: the device and its detached marker band were returned and evaluated by a cross functional team.The device's working length was in good condition, except for the detached marker band.The device's distal tip had a slight epoxy void.Jagged edges were visualized on the distal end of the marker band.The locking feature was present all the way around the marker band's inner diameter (within specifications).The marker band was found to be oval in shape, but cause could not be determined.Based on the device evaluation and investigation, this failure has been determined to be production process related, due to the epoxy void (the epoxy is applied during production of 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
• 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: 14279715
• Report Number: 1721279-2022-00076
• Device Sequence Number: 6323037
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)230730(10)FBC21G27A
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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
• Date Returned to Manufacturer: 04/26/2022
• 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: 04/07/2022
• Initial Report FDA Received Date: 05/04/2022
• 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: ABBOTT: BAREWIRE GUIDE WIRE SIZE UNK; COOK MEDICAL: 7F INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White