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 01/01/2019

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove one right atrial (ra) lead, two right ventricular (rv, one capped and one active) leads, and a left ventricular (lv) lead due to bacteremia.Multiple spectranetics devices (2-14f glidelight laser sheaths, 2-16f glidelights, 11f tightrail sub-c rotating dilator sheath, 13f tightrail sub-c, 11f tightrail (long), 13f tightrail (long), torqmax sheath grip accessory, large visisheath dilator sheath) were used during the extraction procedure.The significant vegetation present on the leads prior to the procedure was removed using an angiodynamics angiovac system.Spectranetics lead locking devices (llds) were inserted into the active leads to provide traction.It was discovered that an lld was present within the capped rv lead from a failed extraction attempt in 2019; the exact procedure date is unk so (b)(6) 2019 was used as the procedure date.The active rv and ra leads were removed without complication.Sutures were used to provide traction to the capped rv lead; during the extraction, the lead broke, but was ultimately removed successfully using a fish tape and additional sutures.While removing the lv lead, it was noted the lead tip was significantly scarred into the lv; the physician used a 16f glidelight to lase within the lv, and with traction, the lead tip finally broke free.The patient''s blood pressure dropped.Transesophageal echocardiography (tee) confirmed a pericardial effusion.A sub-xiphoid window was performed, followed by a sternotomy.A perforation in the distal portion of the coronary sinus was discovered and repaired (mdr #1721279-2023-00032).The patient survived the procedure.This event captures the lld which was discovered within the capped rv lead during the procedure.There was no alleged malfunction of the lld device 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.Lld cut and cap is a known risk of complication with use of the lld device.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 ; 719447-246
• MDR Report Key: 16461484
• MDR Text Key: 310446580
• Report Number: 1721279-2023-00033
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• 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: MEDTRONIC SPRINT QUATTRO 6947/58 RV ICD LEAD; MEDTRONIC STARFIX 4195/88 LV LEAD; OTHER LEAD EXTRACTION DEVICES UNK
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White