MAUDE Adverse Event Report: SPECTRANETICS CORPORATION TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	545-511
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
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 lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 11f tightrail rotating dilator sheath, the rv lead was removed.Switching to the ra lead, dense fibrosis was encountered, and upon attempting removal of the tightrail from the lead, the lead was stuck inside the tightrail device.Several attempts to free the lead from the tightrail were made; however, unsuccessful.Therefore, the lead was cut, and the remaining portion was removed with a cook medical bulldog, spectranetics 16f glidelight laser sheath, and spectranetics large visisheath dilator sheath with no reported patient harm.This report captures the 11f tightrail that entrapped the lead, requiring intervention.
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.A4) patient weight - not available from facility.A5/a6) patient ethnicity and race - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H3/h6) the tightrail was returned; however, device evaluation is pending.A supplemental report will be submitted once evaluation is completed.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.
Additional Manufacturer Narrative
H3) the tightrail was returned with a portion of a lead and lld.Visual inspection found the lld protruding from the proximal end of the tightrail, with heavy biologics present; therefore, unable to determine if the blades were concentric or retracted.Crepitation was present throughout the shaft but holds shape set.The tightrail was soaked, cleaned and re-evaluated and found the lead or coil coming out the distal end, with significant marring on the outer jacket.When the handle halves were separated, minimal biologics were observed, and the trigger pin appeared to be in good working condition; however, there was moderate to heavy wear on the trigger tabs.The end cap, bushing, and barrel/sleeve were easily removed, and the through hole of the barrel was clear but had biologics present on the barrel and barrel tracks.X-ray images showed the lld and lead present within the inner lumen.The tightrail was soaked and cleaned again for re-evaluation, and the lld was removed from the proximal end of the shaft.The tightrail does not hold shape set, and there was no audible crepitation.The blades were rounded with biologics present, unevenly retracted, and not concentric with the outer band.The tightrail was able to be manually actuated and did not appear herniated.The tightrail was soaked and cleaned once more for re-evaluation and holds some shape set with no audible crepitation.The outer jacket was malformed, with biologics seeping through the tri-coils creating chatter marks.The blades are now evenly retracted, concentric with the outer band, with minimal biologics present and manually actuates.H6) based on the device evaluation and investigation, it has been determined that the probable cause of the tightrail becoming stuck on the components within the inner lumen was due to excessive biologic buildup.Heavy biologic buildup can cause resistance within the barrel which can lead to barrel damage and ultimately lead to tightrail failure.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: 24536083
• Report Number: 3007284006-2026-00075
• Device Sequence Number: 18385375
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)271020(10)0303607883
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: 0303607883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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: BOSTON SCIENTIFIC 4087 RA PACING LEAD.; BOSTON SCIENTIFIC 4088 RV PACING LEAD.; SPECTRANETICS LLD LEAD LOCKING DEVICES.
• Patient Age: 62 YR
• Patient Sex: Female