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

Model Number 518-062

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was unavailable from the user facility.The lld was within the extracted lead and the extracted lead was taken by the lead manufacturer's representative.Therefore, it is unavailable for evaluation.Instructions for use for the lld device state: "warning: excessive applied traction forces may impact the lld¿s ability to disengage from a lead".

Event Description

A philips representative reported that during a cardiac lead management case to extract a fractured implantable cardioverter defibrillator (icd) lead, the physician deployed the spectranetics lead locking device (lld) (b)(4) in the lead.The physician was using a 14fr glidelight laser sheath and applying traction to the lld.While applying traction, the lld broke behind the release mechanism of the device.The physician was using a hemostat for traction.The hemostat was secured behind the locking mechanism of the lld.The physician then attached a bulldog mechanism to the remaining piece of lld that was present outside of the lead.This worked well and he was able to establish a traction platform.The lead was then removed without any difficulty.No harm to the patient occurred.

• 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: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8212765
• MDR Text Key: 132224452
• Report Number: 1721279-2019-00003
• Device Sequence Number: 1
• Product Code: DRB
• 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: 01/01/2005,12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP18K24A
• 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: 12/14/2018
• Initial Date FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2018
• 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: 20 YR