MAUDE Adverse Event Report: THE 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	Great Vessel Perforation (2152); Cardiac Perforation (2513)
Date of Event	06/16/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
A4): patient''s weight 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): 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 occlusion.Spectranetics lead locking devices (llds) were inserted into each lead, along with use of suture, to provide traction.Occlusion was noted in the superior vena cava (svc) region, requiring the use of multiple spectranetics devices (12f glidelight laser sheath, 14f glidelight, 16f glidelight, visisheath dilator sheath, 11f tightrail rotating dilator sheath and 13f tightrail) to achieve advancement.All three leads were removed; however, during removal of the ra lead, with the 13f tightrail as the last device in use, the patient''s condition deteriorated.Rescue efforts began, including sternotomy.An svc/ra junction perforation was discovered and repaired.Unfortunately, the patient never left the hospital and died 2 days post-procedure from surgical complications.This report captures the 13f tightrail, the last device 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 17279634
• Report Number: 1721279-2023-00116
• Device Sequence Number: 3584507
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2023

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: 545-513
• Device Catalogue Number: 545-513
• 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: 07/07/2023
• 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 4139 LV LEAD; MEDTRONIC 5568 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH; SUTURE MANUFACTURER/TYPE UNK
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White