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	Fistula (1862)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.H3) the tightrail was discarded, thus no product investigation was performed.H6) per ifu, laceration or tearing of vascular structures is 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.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and right atrial (ra) lead due to non-function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight on the ra lead, steady progression was made down the innominate, through the superior vena cava (svc), and down to the right atrium.Then, targeting the rv lead with the 14f glidelight, advancement was made to the innominate/svc junction, but binding was encountered.Switching to a spectranetics 11f tightrail rotating dilator sheath, progress was made past the binding site, and the ra lead was removed.When removing the tightrail from the patient, the blood pressure dropped, and rescue efforts began, including rescue balloon.The blood pressure stabilized; however, the abdomen became extended and it was unclear where the bleeding was coming from.Therefore, a sternotomy and exploratory laparotomy were performed, but unable to find the source of the bleeding.Angiographic imaging was performed, and detected a fistula between the aorta and innominate vein (mdr #3007284006-2026-00060).The decision was made to abandon the extraction procedure, and the rv lead, along with the lld ez, was cut/capped and remained in the patient.Attempts to unlock the lld ez were unsuccessful (mdr #3007284006-2026-00061).The patient survived the procedure.This report captures the 13f tightrail in use when the fistula 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: 24428890
• Report Number: 3007284006-2026-00060
• Device Sequence Number: 10227212
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)271210(10)0303654224
• 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): 02/24/2026

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: 0303654224
• 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: 02/04/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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: LLD EZ LEAD LOCKING DEVICES; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; PHILIPS LASER SYSTEM; SPECTRANETICS 14F GLIDELIGHT LASER SHEATHS
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White