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

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	07/22/2026
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra), right ventricular (rv), and left ventricular (lv) leads due to bacteremia.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with multiple spectranetics devices (11f tightrail sub-c rotating dilator sheath, 11f tightrail rotation dilator sheath (long), and 14f glidelight laser sheath) on the rv lead, resistance was met under the clavicle with lead on lead binding.Upon reaching the innominate/superior vena cava (svc) junction, the decision was made to switch the ra lead; however, encountered the same binding.Utilizing a spectranetics 13f tightrail rotating dilator sheath, advancement was made down to the svc/ra junction, when the ra lead came free.A pericardial effusion was detected via intracardiac echocardiography (ice), and rescue efforts began, including rescue balloon, pericardiocentesis, cpr, and sternotomy.A large svc perforation was discovered, but was unable to be repaired, and the patient did not survive the procedure.This report captures the tightrail in use when the perforation occurred, requiring intervention, but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
B2) due to failed submission for entering more than 1 outcome, adding here the additional outcomes attributed to adverse event: life threatening and required intervention h3) the tightrail was discarded, thus no product investigation was performed.H6) per ifu, perforation and death are listed as potential adverse events with use of the tightrail device.Additional health effect impact: f15 recognised device or procedural complication.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: 50221186
• Report Number: 3007284006-2026-00416
• Device Sequence Number: 10345719
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)270728(10)0303536672
• 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): 08/11/2026

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: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: 0303536672
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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: Abbott 1458Q LV lead; Abbott 2088TC RA pacing lead; Spectranetics 11F TightRail Dilator Sheath; Spectranetics 11F TightRail Sub-C Dilator Sheath; Spectranetics 14F GlideLight Laser Sheath; Spectranetics CVX-300 Excimer Laser System; Spectranetics LLD EZ Lead Locking Devices; St. Jude Medical LDA2010Q RV ICD lead
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 143 LB
• Patient Race: White