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

Model Number	545-509
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to fracture.A spectranetics lld ez lead locking device (lld ez), along with a cook medical one-tie compression coil, were inserted into the lead to provide traction.Beginning with a spectranetics 9f tightrail rotating dilator sheath, the outer sheath would not enter the access site at the subclavian vein, thus unable to advance to the superior vena cava (svc)/ra junction.During removal, the tightrail got stuck on the lld ez (mdr #3007284006-2025-00137), and both were removed together, along with the one-tie.Upon removal, the lld ez and one-tie could not be removed from the tightrail; therefore, the tightrail was cut to preserve the lead and lld ez length.A cook medical needle¿s eye snare was used to complete the procedure with no reported patient harm.This report captures the 9f tightrail that got stuck on the concomitant devices that had to be removed as a system, potential for harm with recurrence.
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/a6) patient ethnicity and race - not available from facility.B6) relevant tests/laboratory data - not available from facility.H3/h6) the tightrail was not returned, thus no product investigation was performed.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 in two sections, which aligns that the device was intentionally cut by the user.The distal section includes the distal tip and a portion of the outer jacket, measuring 33 cm in length.Visual inspection found heavy biologics at the distal end of the device, and using x-ray, the lld and potential cook medical one-tie were visible inside the lumen.The outer jacket was stretched and ripped, exposing the stretched inner coils.At the distal tip, the blades were extended and the lld mandrel was protruding.The proximal section includes a portion of the outer jacket, strain relief, and device handle, with the working area measuring 26 cm in length.Visual inspection at the location of the separation, the outer jacket appeared ripped, and the inner coils were exposed and stretched.Additionally, the outer sheath was returned covering the outer jacket, and was cut at its blunt end, corresponding to the tightrail being cut.The outer sheath measured approx.11 in., which concludes that approx.5 in.Was not returned (measurement spec is 16 inches +/- 0.20).The total combined length of the distal and proximal section is 80.6 cm, which is outside the measurement spec of 69.1 cm due to the stretching observed.During functional testing, an attempt was made to remove the lld from the tightrail, but the lld moved slightly and remained inside the lumen.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 at the distal tip.It is likely that the tightrail and other components became stuck within the inner coils, resulting in the experienced failure.Type of investigation code b01 replaced (from b17).Investigation findings code c0706 replaced (from c20).Investigation conclusions code d1001 replaced (from d14).All other codes are applicable as listed in the initial mdr.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: 22493188
• Report Number: 3007284006-2025-00136
• Device Sequence Number: 17174023
• Product Code: DRE
• UDI-Device Identifier: 00813132021634
• UDI-Public: (01)00813132021634(17)270106(10)0303373977
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 545-509
• Device Catalogue Number: 545-509
• Device Lot Number: 0303373977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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: COOK MEDICAL ONE-TIE COMPRESSION COIL.; MEDTRONIC RV LEAD (MODEL, TYPE UNK).; SPECTRANETICS LLD LEAD LOCKING DEVICE.
• Patient Age: 7 YR
• Patient Sex: Male