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 Code	Perforation of Vessels (2135)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to redundancy.Spectranetics lld #2 lead locking devices (lld #2s) were inserted into each lead to provide traction.Beginning with a spectranetics glidelight laser sheath on both leads, little progress was made due to heavy calcification.Switching to a spectranetics 13f tightrail rotating dilator sheath on the ra lead, advancement was made through the superior vena cava (svc).A pleural effusion was detected via venogram, and a subclavian perforation was noted (mdr #3007284006-2025-00077).Rescue efforts began, and the tightrail device was used to stop bleeding from the perforation.A rescue balloon was used to tamponade the injury, and a chest drain was placed to remove the blood.The patient stabilized, and venogram showed no effusion, but minimal blood loss was coming from the chest tube.As a result, the decision was made to stop the extraction.No attempt was made to unlock the llds from the rv lead, (mdr #3007284006-2025-00078), or the ra lead (mdr #3007284006-2025-00079), so the leads, along with the llds, were cut and capped and remained in the patient.The patient survived the procedure.This report captures the 13f tightrail device in use within the subclavian when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A2) patient date of birth: not available from facility.A3b) patient gender: not available from facility.A4) patient weight: not available from facility.A5) patient ethnicity: not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history: not available from facility.H3) the tightrail device was discarded, thus no returned product investigation was performed.H6) perforation of vessels 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: 21894259
• Report Number: 3007284006-2025-00077
• Device Sequence Number: 14313399
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)251030(10)FRJ23K30A
• 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): 04/23/2025

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: 10/30/2025
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ23K30A
• 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: 03/27/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• 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: PHILIPS LASER SYSTEM; RA LEAD (MANUFACTURER, MODEL, TYPE UNK); RV LEAD (MANUFACTURER, MODEL, TYPE UNK); SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LLD #2 LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Race: White