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)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

A2): date of birth unk.H3): the device was discarded, thus no investigation could be completed.H6): great vessel perforation and perforation of vessels 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 Description

A lead extraction procedure commenced to remove two right atrial (ra) leads and one right ventricular (rv) lead due to patient requiring an mri compatible system.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath to remove the rv lead, advancement was made to the mid subclavian before stalled progression was encountered.Then, a spectranetics 13f tightrail rotating dilator sheath made progress into the rv when the patient''s blood pressure dropped.An effusion was detected via a transesophageal echocardiography (tee).Rescue efforts began, including sternotomy.Two injury sites were discovered, one in the subclavian and the other on the lateral wall of the superior vena cava (svc).Both perforations were repaired, all 3 leads were removed post-sternotomy, and the patient survived the procedure.This report captures the 13f tightrail in use when the perforations occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: jill jacoby ; 9965 federal drive; colorado springs, CO 80921 ; 719447-260
• MDR Report Key: 18375509
• MDR Text Key: 331127757
• Report Number: 3007284006-2023-00097
• 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: 12/21/2023

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
• 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: 12/21/2023
• 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 1488 RA PACING LEAD.; ABBOTT 1488 RV PACING LEAD.; MEDTRONIC 4076 RA PACING LEAD.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICES.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White