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

Model Number 518-019

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); 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 rv lead which was cut, capped and remained in the patient.Mdr's for reference in this event: 1721279-2020-00095, 00096, 00099.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• 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: 9950592
• MDR Text Key: 189436894
• Report Number: 1721279-2020-00098
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 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: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• 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): Other
• Patient Age: 45 YR
• Patient Weight: 73