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

Model Number 518-019

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

Patient Problems Pulmonary Embolism (1498); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/19/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), a capped right ventricular (rv), an active rv and a left ventricular (lv) lead due to bacteremia.Vegetation was present on the tricuspid valve prior to the procedure.Spectranetics lead locking devices (llds) were inserted in the leads to provide traction.The physician began working to remove the capped rv lead first.It was discovered that this lead had perforated the heart wall during its initial implantation in 1994, and using a spectranetics 14f glidelight laser sheath and spectranetics visisheath dilator sheath, advancement was achieved approximately 3 cm into the subclavian vessel where gentle traction was then applied.The lead pulled back from the rv apex and the patient's blood pressure immediately dropped.Rescue efforts began immediately including rescue balloon and pericardiocentesis.The physician determined that the capped rv lead had perforated the heart wall again during extraction.Pericardiocentesis was effective in treating the patient's blood pressure and no further intervention was required to repair the rv perforation.The 14f glidelight was used to successfully remove the ra and lv leads, and a spectranetics 11f tightrail rotating dilator sheath was used to remove the active rv lead.After all leads were removed from the heart, it was determined that the small vegetation on the tricuspid valve had embolized into the pulmonary artery.The interventional cardiologist was called; the patient's vital signs were not robust enough to remove the vegetation, and the patient was placed on extracorporeal membrane oxygenation (ecmo), and survived the procedure.It was communicated that later the patient was stable and off ecmo.This report captures the lld present in the capped rv lead when the rv apex perforation occurred, requiring intervention.Additionally, this is being reported for the embolization that required medical intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

Patient's weight unk.Relevant tests/laboratory data unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.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
• MDR Report Key: 15411560
• MDR Text Key: 299782580
• Report Number: 1721279-2022-00168
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 09/13/2022

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: 518-019
• Device Catalogue Number: 518-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/13/2022
• 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: BOSTON SCIENTIFIC 0144-64 ACTIVE RV ICD LEAD; MEDTRONIC 4396-86 LV LEAD; OSCOR ZY52JU CAPPED RV PACING LEAD; OXCOR ZY60JU RA PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic