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); Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2) patient's date of birth - not available from facility.A3b) patient's gender - not available from facility.A4) patient's weight - not available from facility.A5) patient's ethnicity - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H3) the device was discarded, thus no device evaluation could be completed.H6) perforation of vessels and great vessel perforation 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 atrial (ra) and a right ventricular (rv) lead due to bacteremia.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath and a spectranetics large visisheath dilator sheath on the rv lead, advancement was made to the innominate, where snowplowing of the lead occurred.Then, switching to a spectranetics 13f tightrail rotating dilator sheath, progress was made to the tricuspid valve; however the patient's blood pressure dropped, and an effusion was seen via intracardiac echocardiography (ice).Rescue efforts began, including pericardiocentesis and sternotomy.A perforation from the superior vena cava (svc)/innominate junction into the svc was discovered and repaired.The ra and rv leads were removed post-sternotomy, and the patient survived the procedure.This report captures the 13f tightrail in use in the area when the perforation occurred, requiring intervention.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: 21638594
• Report Number: 3007284006-2025-00048
• Device Sequence Number: 20959917
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)270102(10)0303370030
• 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): 03/18/2025

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: 0303370030
• 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: 03/06/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2025
• 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 0292 RV ICD LEAD.; BOSTON SCIENTIFIC 7740 RA PACING LEAD.; PHILIPS LASER SYSTEM.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Race: White