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

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Device manufacture date unk because lot number unk.Although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the lv 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.

Event Description

A lead extraction procedure commenced to remove a left ventricular (lv) lead due to non function.Right ventricular (rv) and right atrial (ra) leads were also present in the patient, but were not initially targeted for extraction.However, during preparation for the procedure, the ra lead was found to be damaged.A spectranetics lead locking device (lld) was inserted into the lv and ra leads to provide traction.Multiple spectranetics devices (glidelight laser sheath, tightrail sub-c rotating dilator sheath, tightrail long, visisheath dilator sheath) were used during the procedure.Attempting to remove the lv lead, the physician encountered lead on lead binding with the ra lead, so extraction attempt switched to the ra lead, which was successfully removed.Attempting to remove the lv lead again, it was found to be bound to the rv further distally in the vasculature, so an lld was inserted into the rv lead, and extraction attempt switched to the rv lead.When advancing through the turn of the superior vena cava (svc), the vasculature was found to be very tortuous, with significant lead on lead binding.In the interest of patient safety, the procedure was aborted.The physician did not attempt to unlock the llds from the rv and lv leads; both leads/llds were cut and capped, and remained in the patient (mdr #1721279-2023-00039-rv lead/lld.New leads were implanted, and the patient survived the procedure.This event captures the lld present in the lv lead when it was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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 ; 719447-246
• MDR Report Key: 16513822
• MDR Text Key: 310984881
• Report Number: 1721279-2023-00040
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 4194 LV LEAD.; MEDTRONIC 4067 RA PACING LEAD.; MEDTRONIC 6947 RV ICD LEAD.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LEAD LOCKING DEVICES.; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH.; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS VISISHEATH DILATOR SHEATH.
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White