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

Model Number LLD EZ

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

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 11/27/2020

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove three right ventricular (rv) leads due to cied system/pocket infection.The models of the leads to be removed were as follows: medtronic sprint quattro secure, medtronic sprint quattro and st.Jude medical sj riata.It was reported that the sprint quattro was removed with simple traction.After that, spectranetics lead locking devices (lld''s) were inserted in the two remaining rv leads to provide traction to aid in extraction.A cook medical dilator was first used and then a spectranetics 13f tightrail rotating dilator sheath.It was reported that the riata lead could not be removed due to externalization of the lead''s inner conductors.The physician was reportedly able to free the single coil sprint quattro secure, but could not remove the lead via the subclavian vein.The physician then used a needle's eye snare to successfully extract this lead from a femoral approach.One minute after the extraction, a sudden drop in blood pressure was noticed with a stable blood pressure.Rescue efforts began immediately; transesophageal echocardiography (tee) showed a massive emboli (it was determined that spectranetics devices did not cause nor contribute to the emboli).The patient''s condition deteriorated and resuscitation started.After one hour, the patient was stabilized and extracorporeal membrane oxygenation (ecmo) was used.The riata lead and the lld present within the riata lead were cut and capped and remained in the patient''s body.The physician did not attempt to unlock the lld prior to cutting and capping it within the riata lead.Despite efforts, the patient died a day after the procedure on (b)(6) 2020.This report is being submitted for the lld which was present within the riata lead and was cut, capped, and remained in the patient at the time of the lead extraction 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
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 11055428
• MDR Text Key: 229292930
• Report Number: 1721279-2020-00262
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LLD EZ
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR