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	Hemothorax (1896); Great Vessel Perforation (2152)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to bacteremia with multiple vegetations.Prior to use of any spectranetics devices, the vegetations were removed using angiodynamics-the angiovac system.Then, spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Next, a spectranetics 13f tightrail rotating dilator sheath was used on the rv lead, and lead was removed successfully.Switching to a new 13f tightrail on the ra lead, the lead was removed, and no effusions were detected via transesophageal echocardiogram (tee).However, after several minutes, the patient¿s blood pressure began to decline, and a hemothorax was noted.Rescue efforts began, including sternotomy, and a perforation in the superior vena cava (svc) was discovered and repaired.The patient survived the procedure.This report captures the 13f tightrail device 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.B7) other relevant history - not available from facility.H3) the tightrail was discarded, thus no returned product investigation was performed.H6) great vessel perforation is a known risk 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: 22396200
• Report Number: 3007284006-2025-00126
• Device Sequence Number: 17378735
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)270317(10)0303434065
• 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): 07/03/2025

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 Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: 0303434065
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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: ANGIODYNAMICS THE ANGIOVAC SYSTEM; BOSTON SCIENTIFIC 430-07 RV PACING LEAD; BOSTON SCIENTIFIC 432-03 RA PACING LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White