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); Pericardial Effusion (3271)
Date of Event	02/06/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A4) patient weight - not available from facility.A5) patient ethnicity - not available from facility.A6) patient race - not available from facility.B6) relevant tests/laboratory data - not available from facility.H3) the tightrail was discarded, thus no returned product investigation was performed.H6) perforation of vessels 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.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead, a right atrial (ra) lead, and a left ventricular (lv) lead due to bacteremia.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each of the leads to provide traction.Using a spectranetics tightrail sub-c rotating dilator sheath, spectranetics glidelight laser sheath, and 13f tightrail (long), the rv and ra leads were removed successfully.Then, the 13f tightrail (long) was used on the lv lead and advancement was made down to the coronary sinus (cs) ostium, where traction was applied, and the lv lead was extracted.However, an effusion was noted, and rescue efforts began, including pericardiocentesis and sternotomy.A cs perforation was discovered, but unable to be repaired, and the patient did not survive.This report captures the 13f tightrail in use in the area when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices 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: 21472290
• Report Number: 3007284006-2025-00037
• Device Sequence Number: 3410074
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)270107(10)0303373979
• 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): 02/26/2025

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: 0303373979
• 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: 02/06/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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: ABBOTT 1458Q LV LEAD.; BOSTON SCIENTIFIC 4470 RA PACING LEAD.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES.; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH.; ST. JUDE MEDICAL 7121Q RV PACING LEAD.
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Age: 79 YR
• Patient Sex: Male