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

Model Number	420-006
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient''s date of birth, age unk.A3): patient''s gender unk.A4): patient''s weight unk.A5a./5b.): patient''s ethnicity/race unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3/h6): the evaluation and investigation is ongoing, therefore conclusion not yet available.A supplemental mdr will be submitted upon completion.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly calcified, plaque lesion in the distal superficial femoral artery (sfa).A spectranetics turbo elite laser atherectomy catheter was used to treat the patient.After the first pass was completed through the lesion, the device was pulled back, and it was discovered that the distal marker band had detached.The marker band was successfully retrieved using a cook medical 3 mm balloon with no reported patient harm.This event captures the turbo elite's distal marker band which detached, requiring intervention for retrieval.
Additional Manufacturer Narrative
G3): the device evaluation and investigation was completed on 07sep2023.H3): the turbo-elite catheter and separated distal marker band were returned.The marker band was returned intact to a non-philips balloon catheter.Visual inspection found no damage observed on the working length of the catheter, with exception of the missing marker band.During functional testing, the balloon was cut to remove the marker band.Microscopic inspection revealed the edge of the marker band appeared worn, with no further abnormality.H6): based on the device evaluation and investigation, the cause of the failure could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: 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 ; 719447-2465
• MDR Report Key: 17273234
• Report Number: 1721279-2023-00110
• Device Sequence Number: 3555744
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)250420(10)FBA23D13A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/13/2023

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: 04/20/2025
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA23D13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: COOK MEDICAL .014 300 CM ROADRUNNER GUIDE WIRE.; COOK MEDICAL 6F INTRODUCER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown