MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-062

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 12/19/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a failing right ventricular (rv) lead.The lead was exhibiting increasing impedence, poor sensing and capture.A right atrial (ra) lead was present within the patient but was not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead, along with use of suture, to provide traction.The physician began by using a spectranetics 16f glidelight laser sheath, meeting stalled progression in the subclavian vein.A spectranetics 13f tightrail sub-c rotating dilator sheath was used next, and advancement was successful to the curve of the superior vena cava (svc).Switching back to the 16f glidelight, the physician advanced the device down the svc, the lead pulled free from the rv, and the lead and glidelight were removed from the patient.Approximately 3 minutes later, the patient's blood pressure began slowly dropping.A pericardial effusion was noted via transesophageal echocardiography (tee).Rescue efforts began, including pericardiocentesis (performed x 3), cpr, and sternotomy.An rv apex perforation was discovered and successfully repaired.The patient survived the procedure.This event captures the lld providing traction to the rv lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.Cardiac perforation is a known risk of complication with use of the lld 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: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 16117827
• MDR Text Key: 306878736
• Report Number: 1721279-2023-00010
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)241003(10)FLP22K03A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP22K03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6935 RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SUTURE MANUFACTURER/TYPE UNK
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male