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

Model Number 518-067

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

Patient Problems Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to bacteremia (both of the leads were implanted in 1991).A spectranetics lead locking devices (lld ez) were inserted into each lead to provide traction to the lead and aid in extraction.The physician then chose a spectranetics 14f glidelight laser sheath to attempt removal of the rv lead, but progress stalled in the superior vena cava (svc) region due to calcifications.The physician then targeted the ra lead but progress stalled in the same area.Efforts were focused again on the rv lead, and using a cook medical evolution device, and the rv lead was successfully removed.Attempting to remove the ra lead, the 14f glidelight device and the cook medical evolution device were used alternately and removal was successful.However, after the ra lead was removed, the patient's blood pressure dropped gradually and cardiac tamponade was detected.Rescue efforts began immediately, including drainage and sternotomy.An injury was discovered in the ra, approximately 1 cm.The physician stated this injury was as a result of traction.There was no alleged malfunction of any devices in use during the procedure.This report is being submitted due to the lld being present within and providing traction to the ra lead prior to the time the patient's blood pressure dropped.

• 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: 11143333
• MDR Text Key: 230693457
• Report Number: 1721279-2021-00008
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(10)220601(10)FLP20E29A
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2020

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: 06/01/2022
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLP20E29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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