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); Cardiac Perforation (2513)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3b) patient gender - not available from facility.H3) the tightrail was discarded, thus no returned product investigation was performed.H6) great vessel and cardiac perforation 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.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and two (one capped and one active) right atrial (ra) leads due to cied system/pocket infection.In a previous extraction of the ra lead, attempts were unsuccessful, thus the lead was cut and capped, and a new atrial lead was implanted.A spectranetics lld #2 lead locking device (lld #2) was inserted into the active ra lead, and spectranetics lld ez lead locking devices (lld ezs) were inserted into the capped ra and rv lead to provide traction.Beginning with a spectranetics 9f tightrail sub-c rotating dilator sheath on the active ra lead, heavy fibrosis and lead on lead binding to the capped ra lead was encountered.The active ra lead was removed, and switched to a spectranetics 11f tightrail rotating dilator sheath (long) on the rv lead.However, the rv lead was calcified to the capped ra lead, so upsized to a 13f tightrail (long).After some time, the calcification was removed, and the rv lead was extracted.Continuing with the 13f tightrail with some difficulty, the capped ra lead was eventually removed, but the patient¿s blood pressure dropped.Rescue efforts began, including rescue balloon, pericardiocentesis, and sternotomy.A perforation in the ra and the superior vena cava (svc) were discovered and repaired.The patient survived the procedure.This report captures the 13f tightrail in use when the perforations occurred, requiring intervention.There was no alleged malfunction of the tightrail device in use during the procedure.

• 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: 22553186
• Report Number: 3007284006-2025-00146
• Device Sequence Number: 9785252
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)260610(10)FRJ24F03A
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: 06/10/2026
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ24F03A
• 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: 07/03/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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 RA PACING LEAD (MODEL UNK); MEDTRONIC RA PACING LEAD (MODEL UNK); MEDTRONIC RV LEAD (MODEL, TYPE UNK); SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 9F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS LLD #2 LEAD LOCKING DEVICE; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White