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 02/19/2021

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.A spectranetics lead locking device was inserted into the ra lead to provide a traction platform to aid in extraction (the rv lead was fractured at the clavicle, so an lld was not used).However, the ra lead was bound to the rv lead.Since this was a class ii extraction indication, the physician made the decision to abandon the extraction and cap the lead.He attempted to remove the lld from the ra lead prior to capping, but was unsuccessful.The procedure finished with no reported patient harm.This report is being submitted to capture the lld present within the ra lead that was cut/capped and remained in the patient.

• 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: 11467782
• MDR Text Key: 242916400
• Report Number: 1721279-2021-00034
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)221208(10)FLP20M07A
• 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: 02/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20M07A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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: 63 YR
• Patient Weight: 96