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 Problem Cardiac Perforation (2513)

Event Date 02/22/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead due to infection.The ra and lv leads came out with counter traction only.The rv lead was prepped using a spectranetics lead locking device (lld) and suture to provide traction.A spectranetics sightrail rotating dilator sheath was used first, with no progress achieved.The physician switched to a spectranetics 14f glidelight laser sheath, and after four seconds of lasing in the innominate region, the rv lead came free with ease.When the lead was removed from the body, the patient's blood pressure immediately dropped.Pericardiocentesis was performed to no avail, as clotting had already begun.Additional rescue efforts included ecmo and a chest tube.The patient's blood pressure stabilized and the patient was eventually taken to the or where a sternotomy was performed.It was determined that the rv lead had been implanted through the heart wall, causing an rv perforation when the rv lead was removed.Repair of the perforation was successful and the patient survived the procedure.This report captures the lld providing traction to the rv lead when the rv perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

Patient's weight unk.The device was discarded, thus no investigation could be completed.

• 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: 13864200
• MDR Text Key: 287712067
• Report Number: 1721279-2022-00057
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)240112(10)FPL22A12A
• 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: 02/22/2022

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 Expiration Date: 01/12/2024
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP22A12A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: ABBOTT 1458Q LV LEAD; ABBOTT 2088TC RA PACING LEAD; ABBOTT LDA210Q RV ICD LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS SIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White