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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient''s weight unk.Other relevant history unk.The tightrail guardian was returned and evaluated.Visual inspection found minimal biologics at the distal tip.During functional testing, the device performed as designed and operated as intended.Damage to non-targeted lead is a known risk of complication with use of the tightrail guardian device.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 lead extraction procedure commenced to remove a right ventricular (rv) lead due to redundancy.A right atrial (ra) lead was present in the patient as well, but was not initially targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.The physician chose a spectranetics 11f tightrail guardian motorized dilator sheath to begin the procedure.Advancement was made to the clavicle, then progress stalled.The ra lead, which was not prepped for lead extraction, was coiled in front of the actively dilating tightrail guardian, which resulted in the ra lead being cut.Further progress stalled, so the physician used femoral snaring techniques to grab the rv lead to finish the extraction.However, due to lead on lead binding, the ra lead was almost pulled out along with the rv lead.Both leads were successfully removed; re-implantation of new ra and rv leads was completed.The patient survived the procedure.This report captures the 11f tightrail guardian which cut the ra lead, requiring re-implantation of a new ra lead.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 16659200
• Report Number: 1721279-2023-00053
• Device Sequence Number: 7161225
• 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: CT
• 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
• Report Date (Section B): 03/31/2023

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?: No
• 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: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2023
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White