MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD EZ 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 02/06/2024

Event Type  Injury  

Manufacturer Narrative

A2): patient''s date of birth unk.D4): device lot number, expiration date unk.Partial udi populated.H3): a portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.H4): device manufacture date unk because lot number unk h6): 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 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 right atrial (ra) and two right ventricular (rv, models 6947 and 4086) leads due to cied system/pocket infection.A spectranetics lead locking device (lld) was inserted into the 6947 rv lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath and a spectranetics visisheath dilator sheath, the 6947 rv lead was extracted successfully.Next, a spectranetics lld ez was inserted into the ra lead.Using the same glidelight and visisheath, advancement was made to the tip of the lead; however, the patient''s blood pressure dropped.Rescue efforts began, including rescue balloon, bypass, and sternotomy.A perforation, beginning in the innominate and extending through the superior vena cava (svc) to the ra was discovered (mdr #3007284006-2024-00041).Due to the poor condition of the vessels, the repair was difficult, but eventually completed, with no further attempts to extract the ra lead.The physician did not attempt to unlock the lld ez from the lead, and the ra lead and lld ez were cut and capped and remained in the patient (mdr #3007284006-2024-00042).The 4086 rv lead remained in the patient, with no attempts at extraction.Unfortunately, the patient died the following day, on (b)(6) 2024.This report captures the lld ez in the ra 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.

• Brand Name: LLD EZ LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): 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: 18803801
• MDR Text Key: 336507608
• Report Number: 3007284006-2024-00042
• Device Sequence Number: 1
• Product Code: DRB
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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 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 4086 RA PACING LEAD; MEDTRONIC 4086 RV PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White