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 Tamponade (2226); Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165); Pericardial Effusion (3271)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth and age unavailable.Patient's weight unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to malfunction/lead fracture.Spectranetics lead locking devices (lld''s) were placed in each lead to act as traction during the extraction procedure.Using a spectranetics 14f glidelight laser sheath along with traction from the lld and attempting extraction of the rv lead, he was able to advance to the mid innominate region and progress stalled.He then switched efforts to extract the ra lead and made steady progress to approximately the same region in the innominate, when the patient''s blood pressures dropped down steadily.An effusion and tamponade were detected via transesophageal echocardiography (tee).Rescue efforts commenced immediately including rescue balloon, chest compressions and a sub-sternal pericardial window.The pericardium was drained via this window; the tamponade was resolved and the blood pressure came back to normal.After the patient had remained stable for several minutes, it was decided to resume the procedure using a 16f glidelight along with traction from the lld.Concentrating effort on the rv lead, this lead was successfully removed with very little effort.Again focusing on removal of the ra lead using the same devices, it was noted that when traction was placed on the ra lead and while the glidelight device was in the subclavian vein, the patient''s blood pressure again dropped significantly and tamponade was noted.Rescue efforts began again including rescue balloon; the pericardial drain was repositioned which resolved the tamponade and the patient's blood pressure came back up to an acceptable level.The patient was monitored, with blood pressures staying at an acceptable level.It was decided to abandon this ra lead.The ra lead and the lld present within the lead were cut, capped, and remained within the patient's body.It was reported that the physician did not attempt to unlock the lld prior to cutting and capping the ra lead/lld.Although the exact location of injury was not confirmed, it was reported that the physician was attempting extraction of the ra lead at the time both effusions occurred, traction was being applied prior to the discovery of each effusion, the glidelight device was reported to have only been in the innominate or subclavian regions - and with each effusion that was discovered, pericardial drainage resolved the resulting tamponades.

• 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10818929
• MDR Text Key: 215597108
• Report Number: 1721279-2020-00230
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)220804(10)FLP20H03A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

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: 08/04/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20H03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention