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 01/04/2024

Event Type  Injury  

Manufacturer Narrative

A2): patient's date of birth unk.H3): a portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.H6): although lld cut and 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 ventricular (rv) lead due to cied system/pocket infection, with the patient's pocket eroded.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath, resistance was noted when the catheter was approximately halfway over the lead, with significant adhesions noted to the vessel wall.A femoral snare was used to create a dual traction platform.Manipulation of the lead appeared to pull the lead away from the superior vena cava (svc) wall, and a spectranetics 13f tightrail rotating dilator sheath was then used to advance approximately 2-3 cm beyond the lead''s coil, where progress stalled.Using the glidelight again, 3-4 lasing sequences were performed when the patient's blood pressure dropped and an effusion was detected via transoralesophageal echocardiography (toe).Rescue efforts began immediately, including sternotomy.Perforations to the svc and svc/innominate regions were discovered and a challenging repair was successfully completed (mdr #3007284006-2024-00020).Due to the patient being too unstable to remove the rv lead, the lead/lld were cut in the right atrium (ra) during the sternotomy.There was no attempt to unlock the lld from the lead, and both were cut and capped and remained in the patient (mdr #3007284006-2024-00021).The patient survived the procedure.This report captures the lld within 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.

• 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: 18584722
• MDR Text Key: 333772506
• Report Number: 3007284006-2024-00021
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)251026(10)FLP23K24A
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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
• Device Lot Number: FLP23K24A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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: FEMORAL SNARE MANUFACTURER/TYPE UNK; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ST. JUDE MEDICAL 7120 RV ICD LEAD
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic
• Patient Race: White