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	Perforation of Vessels (2135); Great Vessel Perforation (2152)
Date of Event	03/03/2026
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove two right ventricular (rv) leads (one pacing and one icd) due to non-function.A right atrial (ra) and left ventricular (lv) leads were present within the patient but not targeted for extraction.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a shockwave medical balloon, large amounts of air was observed, along with fault codes, so another balloon was used throughout the innominate and superior vena cava (svc) with no issue.Then, utilizing a spectranetics 14f glidelight laser sheath and a spectranetics 11f tightrail rotating dilator sheath, the rv pacing lead was removed.Next, using a spectranetics 16f glidelight laser sheath, along with a spectranetics large visisheath dilator sheath, little forward progress was made so switched to a spectranetics 13f tightrail sub-c.Almost reaching the svc, the same 16f glidelight was used again, with slow advancement through the innominate to the svc.At the mid svc, the rv icd lead, along with the lld ez broke (mdr #3007284006-2026-00101), and the decision was made to switch to a spectranetics 13f tightrail rotating dilator sheath (long).An arthrex fiberwire suture was tied to the remainder of the rv icd lead in order to maintain the traction platform.While attempting to remove the rv icd lead, the ra lead became dislodged, thus prepped with an lld ez for removal.With the same 14f glidelight, the ra lead was removed and targeted the rv icd lead again with the 13f tightrail; however, the device was unable to advance over the proximal coil of the lead.The patient was becoming unstable, so the devices were removed from the body, but the patient¿s blood pressure dropped.Rescue efforts began, including rescue balloon and sternotomy.A perforation to the innominate/svc junction was discovered, and patient was put on bypass but there was no longer any blood in the heart.The patient did not survive the procedure.This report captures the tightrail device 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
H3) the tightrail was discarded, thus no product investigation was performed.H6) perforation of vessels, great vessel perforation, and death are known risks of complication 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 ; 719447-2465
• MDR Report Key: 24690906
• Report Number: 3007284006-2026-00102
• Device Sequence Number: 9706622
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)271013(10)0303604150
• 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): 03/25/2026

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: 0303604150
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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: ARTHREX FIBERWIRE SUTURE.; BOSTON SCIENTIFIC 0180 RV ICD LEAD.; MEDTRONIC 5076 RA PACING LEAD.; MEDTRONIC 5076 RV PACING LEAD.; PHILIPS LASER SYSTEM.; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES.; ST. JUDE MEDICAL 1056T LV LEAD.
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White