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	Perforation of Vessels (2135); Great Vessel Perforation (2152); Cardiac Perforation (2513)
Date of Event	07/11/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
A4): patient's weight unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.D4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk h6): perforation of vessels, great vessel perforation, cardiac perforation, 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 atrial (ra), a right ventricular (rv), and a left ventricular (lv) lead due to the system giving inappropriate shocks.Spectranetics lead locking devices were inserted into each lead to provide traction.Multiple spectranetics devices (11f tightrail sub-c rotating dilator sheath, 11f tightrail long) were used to ultimately extract all three leads.However, while removing the ra lead using the 11f tightrail (long), a continuous perforation (extending from the innominate vein through the superior vena cava (svc) to the right atrium) was discovered.Rescue efforts began, including bypass and sternotomy.Patches were placed through the entire perforated region and 3 new leads were implanted through the patches.The patient survived the procedure, but died the following day.This report captures the 11f tightrail long, in use 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 17460240
• Report Number: 3007284006-2023-00007
• Device Sequence Number: 7189724
• Product Code: DRE
• UDI-Device Identifier: 00813132020880
• UDI-Public: 00813132020880
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

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: 545-511
• Device Catalogue Number: 545-511
• 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: Not provided
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 6944 RV ICD LEAD; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1458Q LV LEAD; VIATRON LML49JB RA PACING LEAD
• Outcome Attributed to Adverse Event: Death; Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White