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

Model Number 518-062

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

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Date 07/07/2016

Event Type  Injury  

Event Description

An (b)(6) female presented for extraction of three cardiac leads due to cied system/pocket infection.All three leads were prepped with spectranetics lead locking devices.A spectranetics glidelight laser sheath was selected to perform the extraction via the cephalic vein.Lasing commenced and the cephalic vein was torn at the device entry point while lasing.It was decided to abandon the extraction and 3 lead locking devices were cut and capped within the patient.The patient survived the procedure.This report is being made against the lld cut and capped in the ra lead.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5840213
• MDR Text Key: 52285339
• Report Number: 1721279-2016-00094
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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: 84 YR
• Patient Weight: 76