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 04/06/2023

Event Type  Injury  

Manufacturer Narrative

A4): patient's weight: unk.A5a./5b.): patient's ethnicity/race: unk.B7): other relevant history: unk.D4): device lot number, expiration date: unk h3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): 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.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function/fracture.A right atrial (ra) and a left ventricular (lv) lead was present in the patient as well, but not initially targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.Using a spectranetics glidelight laser sheath in the attempt to remove the lead, the glidelight advanced no further than the lead''s ring electrode.Traction was applied, the rv lead came free, and the patient's blood pressure dropped.Rapid development of a pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts began, including rescue balloon and pericardiocentesis.The patient stabilized after the pericardiocentesis, not requiring a sternotomy; an rv perforation was suspected.The physician believed it was highly likely that the rv lead was implanted through the rv wall, which caused the effusion when it was removed.A new rv lead was implanted, and while testing the ra lead, it was found to be non functional as well.The ra lead was removed without complication and a new ra lead was re-implanted.The lv lead remained in the patient with no issues.The patient survived the procedure.This report captures the lld providing traction within the rv lead when the suspected perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 16837619
• MDR Text Key: 314267742
• Report Number: 1721279-2023-00066
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; ST. JUDE MEDICAL 1056T LV LEAD; ST. JUDE MEDICAL 2088 RA PACING LEAD; ST. JUDE MEDICAL 7120Q RV ICD LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female