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

Model Number 518-019

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight unavailable.The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction and re-implantation procedure commenced to remove a right atrial (ra) lead due to malfunction.The lead was implanted in 1992 and was reportedly a tined lead.A spectranetics lead locking device (lld) was inserted into the lead to provide a traction platform to aid in the lead''s extraction.The physician began by using a spectranetics glidelight laser sheath, advancing to the subclavian.He then switched to a spectranetics tightrail rotating dilator sheath and was able to progress to the high superior vena cava (svc).During this time, the ra lead came free while traction was being applied.The patient's blood pressure did not drop rapidly and a pericardial effusion was not evident initially, but was eventually detected.Rescue efforts began.A right atrial (ra) injury was discovered and a pericardiocentesis was performed, draining 175cc of blood.The ra injury reportedly repaired itself.Re-implantation was successful, the patient survived the procedure and is reportedly doing well.This report is being submitted to capture the lld present within the ra lead that provided traction to the lead and an ra perforation occurred, requiring intervention.There was no alleged malfunction of the lld during the 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 (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12207812
• MDR Text Key: 263517885
• Report Number: 1721279-2021-00134
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023041
• UDI-Public: (01)20813132023041(17)221222(10)FLC20M21A
• 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: 06/22/2021

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: 12/22/2022
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC20M21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• 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): Required Intervention
• Patient Age: 72 YR