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 Great Vessel Perforation (2152)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): great vessel perforation is a known risk 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 a right atrial (ra) and a right ventricular (rv) lead due to non-function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics tightrail sub-c rotating dilator sheath, then switching to a 13f spectranetics tightrail rotating dilator sheath on the ra lead, the lead was removed.However, after approximately 30 seconds, an effusion was detected on transesophageal echocardiography (tee) and the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon, sternotomy, and bypass.A posterior superior vena cava (svc) perforation, a few cm above the svc/ra junction was discovered and repaired.The remaining rv lead (containing an lld #2) was found to be heavily fibrosed into the svc wall, and it was determined the lead would not be removed.An attempt was made to unlock the lld #2 from the rv lead, but was unsuccessful; therefore, the rv lead/lld were cut and capped and remained in the patient (mdr#: 3007284006-2024-00025).The patient survived the procedure.This report captures the 13f tightrail in use when the perforation occurred, requiring intervention.There was no malfunction of the 13f tightrail 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18646352
• MDR Text Key: 334610049
• Report Number: 3007284006-2024-00014
• 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: FRJ23L21A
• 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: 11/21/2023
• 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 430-02 RV PACING LEAD.; MEDTRONIC 4068 RA PACING LEAD.; SPECTRANETICS LEAD LOCKING DEVICES.; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White