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 Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A lead extraction procedure commenced to remove 3 leads: two right ventricular (rv) leads (one was active and one was capped), and one right atrial (ra) lead due to needing placement of an mri conditional biventricular pacemaker.During preparation of the leads for extraction, a spectranetics lead locking device (lld) was inserted into each lead to act as a traction platform to aid in each lead's extraction.To begin the procedure, the pocket was opened and the physician noted that while excising the capsule around the pacemaker, the capsule was encased in calcified tissue.The physician used multiple tools during the procedure.While attempting to extract the ra lead, the physician was able to reach near the tip of the lead, but was unsuccessful with multiple countertraction attempts (using lld which was present within the ra lead).He then chose to use a 20mm goose neck snare to grab the very tip of the tined lead and successfully freed the lead from the atrial wall and pulled it out of the patient's body.Five minutes later, a pericardial effusion was noted.Rescue efforts commenced immediately, including sternotomy, and a nickel sized perforation was discovered in the right atrium.Repair to the injury was successful and the patient survived the procedure.It was reported that the two rv leads were also successfully extracted and the reimplantation was also successful, after the injury repair was complete.There were no alleged malfunctions of any spectranetics devices in use during the procedure.This report is being submitted because although the effusion was detected after use of the goose neck snare, multiple countertraction attempts were made prior to extraction of the ra lead, with use of the lld as the traction platform.

• 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: 10521090
• MDR Text Key: 207705020
• Report Number: 1721279-2020-00189
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)220508(10)FLP20E06A
• 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: 01/01/2005,08/14/2020

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: 05/08/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20E06A
• 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: 08/14/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR