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

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 08/28/2019

Event Type  Injury  

Manufacturer Narrative

Patient date of birth unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable because device lot number is 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 the patient's diagnosis of heart block.It was mentioned that this was a right sided lead extraction, and that the ra and lv leads were extracted successfully without complication.While the physician attempted to extract the rv lead, utilizing spectranetics devices including a lead locking device (lld), the team noted there were significant adhesions within the vasculature that required switching back and forth between devices to progress.During this attempt, the patient's blood pressure dropped.Rescue efforts began immediately, including sternotomy.An anterior tear of the right atrium was discovered.The physician successfully repaired the tear and the rv lead and lld were removed post sternotomy.The patient survived the procedure.There was no reported malfunction of any spectranetics devices in use during the procedure.

• 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: 9535610
• MDR Text Key: 175261759
• Report Number: 1721279-2019-00226
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/05/2019

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 Model Number: 518-062
• Device Catalogue Number: 518-062
• 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: 12/05/2019
• Initial Date FDA Received: 12/31/2019
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75