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

Model Number 545-513

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 01/15/2024

Event Type  Death  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.However, neither lld could reach the tip of the leads, despite use of a clearing stylet.Significant calcium was noted in the pocket at the beginning of the procedure, so the case began with a spectranetics 11f tightrail sub-c rotating dilator sheath.Minimal progress could be made; therefore, multiple spectranetics devices (14f and 16f glidelight laser sheaths, large visisheath dilator sheath used with the 16f glidelight, and 13f (long) tightrail) were used, alternating back and forth multiple times between the leads to attempt advancement.Despite efforts, progress could not be made past the subclavian vein, and none of the devices went beyond the area where each lld was providing traction.Eventually, while using the 13f tightrail (long) on the ra lead, the patient's blood pressure slowly fell, even while receiving medication support from anesthesia personnel.No obvious injury was detected via transesophageal echocardiography (tee), but rescue efforts began, including sternotomy and bypass.A subclavian perforation of significant size, possibly posterior, was discovered, and both leads were found to be heavily calcified and embedded the entire way into the subclavian vein.Attempts to repair the perforation continued for approximately 2 hours, but the patient passed away during rescue efforts.This report captures the 13f tightrail (long), 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.

Manufacturer Narrative

A2): patient's date of birth unknown.A4): patient's weight unknown.A5a./5b.): patient's ethnicity/race unknown.H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels 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.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Type of Device: 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 ; 719447-246
• MDR Report Key: 18646208
• MDR Text Key: 334610189
• Report Number: 3007284006-2024-00029
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2024

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
• Device Operator: Health Professional
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ23H08A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT 2088TC RA PACING LEAD; BOSTON SCIENTIFIC 0292 RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Life Threatening; Death; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male