MAUDE Adverse Event Report: SPECTRANETICS CORPORATION TIGHTRAIL SUB-C ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	560-013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non-function.A spectranetics lld lead locking device (lld) was inserted into the lead to provide traction.Beginning with a spectranetics 13f tightrail sub-c rotating dilator sheath, there was some difficulty getting into the subclavian vein, and more bleeding than expected was coming from the pocket.Upon removal of the tightrail sub-c, the bleeding had worsened but was attributed to the entry into the vessel and how deep the lead was implanted.Switching to a spectranetics 13f tightrail rotating dilator sheath (long), advancement was made near the tricuspid valve and stalled.Switching to a spectranetics 16f glidelight laser sheath, the rv lead was removed; however, the patient¿s blood pressure dropped, and bleeding was noted once again.A perforation to the axillary vein into the subclavian was identified, and rescue efforts began, including holding pressure on the injury, and blood products were administered.After several hours, the patient was hemodynamically stable, and a stent was placed.The patient survived the procedure.This report captures the tightrail sub-c in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A4) patient weight - not available from facility.H3) the tightrail sub-c was discarded, thus no product investigation was performed.H6) per ifu, perforation is listed as a potential adverse event with use of the tightrail sub-c 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.

• Brand Name: TIGHTRAIL SUB-C ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 24089948
• Report Number: 3007284006-2026-00016
• Device Sequence Number: 10469561
• Product Code: DRE
• UDI-Device Identifier: 00813132022808
• UDI-Public: (01)00813132022808(17)270730(10)0303538622
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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 Model Number: 560-013
• Device Catalogue Number: 560-013
• Device Lot Number: 0303538622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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: BOSTON SCIENTIFIC 0181 RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White