MAUDE Adverse Event Report: Spectranetics Corporation TightRail Rotating Dilator Sheath; Dilator, Vessel, For Percutaneous Catheterization

Model Number	545-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra), right ventricular (rv), and left ventricular (lv) lead due to bacteremia.Spectranetics lld lead locking devices (llds) were inserted into each lead to provide traction.Beginning with multiple spectranetics devices (glidelight laser sheath, tightrail sub-c rotating dilator sheath, and 11f tightrail rotating dilator sheath) the ra and rv lead were successfully removed.Targeting the remaining lv lead with the 11f tightrail, the lv lead was extracted, and the tightrail was removed from the body.However, a few minutes later, the patient's blood pressure dropped, and rescue efforts began, including bypass and sternotomy.A perforation to the coronary sinus (cs) was discovered and repaired, and the patient survived the procedure.This report captures the tightrail 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
A3b) patient gender - not available from facility.A4) patient weight - not available from facility.A5/a6) patient ethnicity/race - not available from facility.B7) other relevant history - not available from facility.H3) the tightrail was discarded, thus no product investigation was performed.H6) per ifu, perforation listed as a potential adverse event with use of the tightrail 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 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 ; +1(719)447-2465
• MDR Report Key: 50533406
• Report Number: 3007284006-2026-00434
• Device Sequence Number: 12250110
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• 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): 08/31/2026

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: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: 0303799973
• 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: 08/24/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2026
• 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 4054 RA pacing lead.; Boston Scientific 4473 RV pacing lead.; Boston Scientific 4591 LV lead.; Spectranetics 11F TightRail Sub-C Dilator Sheath.; Spectranetics CVX-300 Excimer Laser System.; Spectranetics GlideLight Laser Sheath.; Spectranetics LLD Lead Locking Devices.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 68 YR
• Patient Sex: Female