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 Problems Perforation of Vessels (2135); Great Vessel Perforation (2152); Pericardial Effusion (3271)

Event Date 01/04/2024

Event Type  Death  

Event Description

A lead extraction procedure commenced to remove two right ventricular (rv) leads due to occlusion, non function, lead fracture, and a redundant lead (models 0180 and 1580).Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 13f tightrail rotating dilator sheath and the tightrail outer sheath on the 0180 rv lead, dense fibrosis and calcium were encountered, with chunks of calcium being removed via the tightrail.It was difficult to consistently monitor the patient''s status and blood pressure, and at some point during the procedure, the patient''s blood pressure dropped.Rescue efforts began, including rescue balloon.Contrast was used proximal and distal to the balloon to look for signs of injury, with none detected.The balloon was deflated, and transesophageal echocardiography (tee) detected an effusion.The patient''s blood pressure was extremely low for an extended period of time, and the patient went into ventricular tachycardia (vt), requiring defibrillation.Further rescue efforts included pericardiocentesis, rapid infusion, and cpr.Due to continuing blood loss, a sternotomy was performed.A 0.5-1 cm perforation was discovered in the innominate/superior vena cava (svc) region and repaired.The physician chose to abandon further extraction attempts.There was no attempt to unlock the llds from the leads, and the 0180 rv lead/lld (mdr #3007284006-2024-00016) and the 1580 rv lead/lld (mdr #3007284006-2024-00018) were cut and capped and remained in the patient.The patient survived the procedure.The night of the procedure, it was determined that the patient experienced brain injury from the extended low blood pressure during the lead extraction attempt.Additionally, a liver laceration was discovered (occurred during cpr and not device related) and repaired.However, seven days post-procedure, on (b)(6) 2024, the patient died.This report captures the tightrail 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 unk.A4): patient''s weight unk.B6): relevant tests/laboratory data unk.H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels, great vessel 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.

• 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: 18584443
• MDR Text Key: 333761421
• Report Number: 3007284006-2024-00017
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)250808(10)FRJ23H08A
• 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: 01/25/2024

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: 01/25/2024
• 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: BOSTON SCIENTIFIC 0180 RV ICD LEAD; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1580 RV ICD LEAD
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White