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

Model Number	545-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Cardiac Perforation (2513)
Date of Event	08/27/2024
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 non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath on the ra lead, the lead was successfully extracted.Next, while working on the rv lead, the philips laser system (used to power the glidelight) displayed an error code.After several unsuccessful attempts to resolve the error code, a spectranetics 11f tightrail device was used to progress down the vasculature.However, after reaching the superior vena cava (svc) region, an effusion was noted via transesophageal echocardiography (tee), followed by a drop in the patient's blood pressure.Rescue efforts began immediately, including rescue balloon and sternotomy.An svc/ra junction perforation was discovered and repaired.The rv lead was removed post-sternotomy, and the patient survived the procedure.This report captures the 11f tightrail in use when the perforation occurred, requiring intervention.There was no alleged malfunction of the tightrail during use in the procedure.
Additional Manufacturer Narrative
A2): patient date of birth unk.A3b.): patient gender unk.B7): other relevant history unk.H3): the tightrail was not returned, thus no returned product investigation was performed.H6): great vessel and cardiac 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.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 20176959
• Report Number: 3007284006-2024-00184
• Device Sequence Number: 15634018
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)260424(10)FRK24D24A
• 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): 09/09/2024

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: 04/24/2026
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK24D24A
• 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: 08/27/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; PHILIPS LASER SYSTEM; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American