MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove three leads: a right atrial (ra) lead, a right ventricular (rv) lead and a left ventricular (lv) lead due to non function.With use of three spectranetics lead locking devices (lld's) to act as traction platforms within each lead and spectranetics tightrail sub-c and 13f rotating dilator sheaths, the procedure was underway.The physician targeted the ra lead for removal first, and this lead was successfully extracted without complications.Next, the physician was attempting to extract the rv lead using the 13f tightrail device and lld when at that time, the patient's blood pressure dropped.At first, it was thought that excessive traction forces were responsible for the drop in blood pressure, by possible inverting the rv during extraction attempt, but blood pressure did not respond with release of traction.Rescue efforts began immediately, with use of a spectranetics bridge occluding balloon.The bridge balloon was deployed and inflated in the superior vena cava (svc) per protocol.Cpr then began, along with other life saving methods; the patient's blood pressure did not respond.A sternotomy was performed and a tear was discovered in the posterior svc region.The physician had access to the tear at 8 minutes 50 seconds after the patient began to decline.As the surgeon began to repair the injury, he stated he did not see the inflated bridge balloon within the svc.As the electrophysiologist started to deflate the bridge balloon, the team noticed there was blood being drawn back into the syringe, indicating that the bridge balloon's integrity had been compromised.The team felt that the bridge was compromised from the coils of the rv lead, from chest compressions during cpr and/or from the surgeon as he was performing the sternotomy.The repair of the svc injury was successful.The physician chose to not remove the rv and lv leads.He attempted to unlock the lld's that were present in each lead, but the attempt to unlock was unsuccessful.The rv and lv leads, along with the lld's present in each lead, were cut, capped, and remained in the patient.The patient survived the procedure.This report is being submitted to capture the lld that was present within the ra lead which was cut, capped and remained in the patient.Other mdr's for reference in this event: 1721279-2020-00095, 00096, 00098.

Manufacturer Narrative

On 27 april 2020, postmarket surveillance analyst spoke with the rep by phone, who was present at the procedure.Correction information was provided at that time that an lld was not in use within the lead.This supplemental report is being submitted to confirm that there was no lld in use within this lead, no adverse event occurred, and this is no longer a reportable event.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9950596
• MDR Text Key: 196082347
• Report Number: 1721279-2020-00099
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS BRIDGE OCCLUDING BALLOON; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH; ST. JUDE MEDICAL 1458Q LV PACING LEAD; ST. JUDE MEDICAL 1888TC RA PACING LEAD; ST. JUDE MEDICAL 7020 RV ICD LEAD
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 73