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

Model Number 518-062

Device Problem Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2021

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide the traction platform to aid in extraction.After successfully removing the ra lead, the physician attempted to remove the rv lead.After beginning with a spectranetics 16f glidelight laser sheath, the physician switched to a spectranetics 13f tightrail rotating dilator sheath due to stalled progress with use of the glidelight device.After making small progress with the 13f tightrail device, the physician decided to go back to the 16f glidelight device and add a spectranetics visisheath dilator sheath.The physician made some progress, but the ct surgeon recommended that the procedure be stopped.At that time the glidelight and visisheath devices were removed and the physician decided to cut the portion of the rv lead that was extending outside of the pocket.The lld remained within this rv lead; the physician attempted to unlock the device prior to capping but was unsuccessful.The pocket was then closed.This report is being submitted to capture the lld which was present in the rv lead and was cut, capped and remained in the patient.There was no reported patient harm.

• 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: 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 11467761
• MDR Text Key: 241012806
• Report Number: 1721279-2021-00033
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)221005(10)FLP20K02A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Exemption Number: 5645646
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20K02A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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): Other
• Patient Age: 73 YR
• Patient Weight: 100