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

Model Number 518-062

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/20/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), right ventricular (rv) and a left ventricular (lv) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician began by using a spectranetics 14f glidelight laser sheath and a large visisheath dilator sheath and successfully extracted the ra lead.The 14f glidelight was then used to attempt extraction of the rv lead.The physician encountered stalled progression within the superior vena cava (svc) and upsized to a 16f glidelight, using the same visisheath, to continue extraction attempt of the rv lead.Some advancement was made, but progress stalled at the base of the svc (near the ra).While the physician was trying to get through the binding site in this area, the patient¿s blood pressure dropped.Rescue efforts began, including use of a rescue balloon and sternotomy.An svc perforation was discovered and was successfully repaired (mdr #1721279-2022-00194).The rv lead (mdr #1721279-2022-00195) and lv lead (mdr #1721279-2022-00196) were not removed.The physician did not attempt to unlock the llds from the leads before they were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld present in the rv lead which was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Although lld cut/cap is a known risk of complication with the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• 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 (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15764564
• MDR Text Key: 303397859
• Report Number: 1721279-2022-00195
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• 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
• Treatment: BOSTON SCIENTIFIC 4087 RA PACING LEAD; BOSTON SCIENTIFIC GUIDANT 0158 RV ICD LEAD; MEDTRONIC 4592 LV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White