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

Model Number 518-019

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Patient's weight unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead, implanted in 2013 due to non function.A spectranetics lead locking device (lld) was placed within the rv lead to provide a traction platform to aid in extraction.The physician started by using a spectranetics 14f glidelight laser sheath but could not advance past the mid clavicular region.He then chose to upsize to a 16f glidelight device, which advanced to the right ventricle near the lead's shocking coil.Immediately, an effusion was detected via transesophageal echocardiography (tee).The patient's blood pressure dropped.Tamponade presented, and a pericardiocentesis was performed via a sub xiphoid thoracotomy.The pressure was successfully relieved and the extraction resumed (please reference mdr 1721279-2021-00010 which captures the effusion which was detected immediately after use of the 16f glidelight device).However, the rv lead was unable to be freed from the rv apex.Subsequently, the rv lead with the lld present inside the lead was cut, capped and remained in the patient's body.The physician attempted to unlock the lld prior to cutting and capping the rv lead, but was unsuccessful.The re-implantation of a new lead was successful and the patient survived the procedure.This report captures the lld which was present within the rv lead and both were cut, capped and remained in the patient's body.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 11243810
• MDR Text Key: 232858249
• Report Number: 1721279-2021-00011
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)220729(10)FLC20G28A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 01/04/2021

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: 07/29/2022
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC20G28A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• 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: 35 YR