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

Model Number	560-009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
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 of the superior vena cava (svc).Spectranetics lld ez lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the lv lead, progress stalled.Next, a spectranetics 11f tightrail sub-c was used, alternating between the three leads to attempt advancement down the vasculature.While the tightrail sub-c was on the ra lead in the svc region, the patient's blood pressure dropped.Rescue efforts began immediately, including sternotomy, and an svc perforation was discovered and repaired.After the repair was complete, the lld ezs were unlocked from the leads and removed, and the leads were abandoned in the patient.At that time, the decision was made to replace the tricuspid valve (tv), since the valve was previously determined to have severe tricuspid regurgitation (tr).While working on the valve, it was difficult to control the bleeding, requiring pharmacologic help, as the patient had a coagulation disorder.Unfortunately, the patient did not survive.The surgeon believed the death to be from severe liver failure, related to the tv replacement, occurring after completion of the svc repair.This report captures the 11f tightrail sub-c in use when the perforation occurred, requiring intervention.Although a patient death resulted, the death was not related to the lead extraction procedure.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
H6): although vascular perforation is a known risk of complication with use of the tightrail sub-c device, the tightrail sub-c was in use within the svc.In the spectranetics ifu, it states the tightrail sub-c should only be used to minimally enter the vessel.Do not attempt to enter the svc structure or attempt to navigate the tightrail sub-c sheath into bends beyond the convergence of the innominate and brachiocephalic veins, as vessel wall or cardiac lead damage may occur.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 SUB-C 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: 19680211
• Report Number: 3007284006-2024-00139
• Device Sequence Number: 3166203
• Product Code: DRE
• UDI-Device Identifier: 00813132022785
• UDI-Public: 00813132022785
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• 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): 07/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: 560-009
• Device Catalogue Number: 560-009
• 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: 06/10/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: BIOTRONIK SENTUS LV LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1488 RA PACING LEAD; ST. JUDE MEDICAL 1488 RV PACING LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White