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

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

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

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight unk.Device model number, lot number, catalog number, expiration date, udi unk.Device 510k number 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 three leads: a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead due to bacteremia and septic (b)(6).Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Using a spectranetics 14f glidelight laser sheath, the rv lead was successfully extracted.Attempt to remove the ra lead was next.Using the 14f glidelight device, binding was noted at the innominate juncture and superior region of the superior vena cava (svc).The ra lead was extracted and the patient's atrial pressure began to drop slowly.Transesophageal echocardiography showed a growing pericardial effusion.Rescue efforts began immediately, including rescue balloon and pericardiocentesis.The patient's pressure acutely rose again but remained at a low baseline (70¿s systolic) before starting to fall again.A sternotomy was performed and the cardiothoracic (ct) surgeon discovered a perforation in the innominate region (innominate perforation captured in mdr 1721279-2021-00181) and small perforation in right atrium.The lv lead was removed successfully after sternotomy via a transvenous approach.The patient did not go on cardiopulmonary bypass, the perforations were successfully repaired and the patient initially survived the procedure.However, the philips representative was informed on 14 sept 2021 that the patient did not recover from the surgery and passed away on (b)(6) 2021.This report captures the lld providing traction for the ra lead when the small right atrial perforation occurred, requiring intervention.Although the patient died, the death is captured in mdr 1721279-2021-00181.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: 12555243
• MDR Text Key: 282261738
• Report Number: 1721279-2021-00182
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; MEDTRONID 4196 LV LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLDS IN RV AND LV LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR