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 Pleural Effusion (2010); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Relevant tests/laboratory data unk.Other relevant history 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.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to a cied system/pocket infection (leads had been implanted 276 months).A spectranetics lead locking device (lld ez) was inserted in the ra lead to provide traction.The physician used a 16f glidelight laser sheath, and the ra lead was extracted; however, the physician noticed a chunk of tissue at the end of the ra lead.It was noted there was considerable scar and tissue ingrowth.The patient's blood pressure dropped within 30 seconds of extracting the ra lead.The anesthesiologist administered medication that increased the blood pressure.The physician then safely and successfully extracted the rv lead while the blood pressure was still rising from medication.A transesophageal echocardiography probe (tee) was placed and a large effusion was noted.A subxiphoid approach was used with a drainage tool, and the patient's blood pressure kept dropping until the physician evacuated the blood from the pleural space.Blood pressure stabilized but then dropped again.A sternotomy was performed and a perforation was identified in the ra.The perforation was repaired and the patient survived the procedure.This report captures the lld providing traction to the ra lead when the ra 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
• MDR Report Key: 12587061
• MDR Text Key: 281147900
• Report Number: 1721279-2021-00185
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 1148T RA PACING LEAD; MEDTRONIC 5024M RV PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR