MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL GUARDIAN MOTORIZED DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	575-011
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced to remove two leads.The physician chose a spectranetics 11f tightrail guardian motorized dilator sheath to treat the patient.During removal of the 2nd lead, the tightrail guardian displayed an unrecoverable error state (ure) and could no longer be used.A 2nd tightrail guardian was opened, and the case was completed with no reported patient harm.During device evaluation, it was discovered that the blades of the tightrail guardian were in an extended position past the distal tip, resulting in sharp edges.This report captures the 11f tightrail guardian with blades extended, sharp edges, potential for harm.
Additional Manufacturer Narrative
Patient inforamtion: unknown.Relevant tests/laboratory data: unknown.Other relevant history: unknown.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
This event is no longer reportable for the tightrail guardian reported for sharp edges.Upon further review, the device was returned with the blades retracted and not in an extended position.There is no potential for harm.
Additional Manufacturer Narrative
B5/h2): this event is no longer reportable.G3): further review of device evaluation occurred 10apr2023.H3): further review of device evaluation confirmed that the tightrail guardian was returned with the blades retracted within the distal tip.After the device evaluation began was when the blades were extended during manipulation of the device.H6): based on further review of the device evaluation, this event is no longer reportable.It was determined that the tightrail guardian''s blades were retracted upon return of the device.Certain h6 codes submitted on the initial mdr are no longer applicable and updated with: investigation findings code 213 (replaces 3233), and investigation conclusions code 67 (replaces 11).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: SPECTRANETICS TIGHTRAIL GUARDIAN MOTORIZED DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 16518694
• Report Number: 1721279-2023-00044
• Device Sequence Number: 14278238
• Product Code: DRE
• UDI-Device Identifier: 00813132027438
• UDI-Public: (01)00813132027438(11)221129(17)241129(10)CNB22L29A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K223472
• 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,Followup
• Report Date (Section B): 04/18/2023

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: 11/29/2024
• Device Model Number: 575-011
• Device Catalogue Number: 575-011
• Device Lot Number: CNB22L29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• 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: 03/09/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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: LEADS MANUFACTURERS/MODELS UNK; TRACTION USED FOR LEADS, MANUFACTURER/TYPE UNK
• Patient Sex: Unknown