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 03/06/2024

Event Type  Injury  

Manufacturer Narrative

A2): patient''s date of birth unk b6): relevant tests/laboratory data 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 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.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.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 and a spectranetics large visisheath dilator sheath, advancement was achieved to the superior vena cava (svc)/ra junction.However, the patient''s blood pressure dropped and rescue efforts began, including rescue balloon and sternotomy.A perforation in the svc/ra junction was discovered and repaired (mdr #3007284006-2024-00064).During rescue efforts, the saw used to perform the sternotomy, caused an innominate perforation which was repaired.Subsequently, it was decided to abandon any further extraction attempt of the lead.There was no attempt to unlock the lld ez from the lead before the lead/lld were cut and capped, and remained in the patient (mdr #3007284006-2024-00065).The patient survived the procedure.This event captures the lld ez within the rv lead which was cut and capped and remained in the patient.

• 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: 19001016
• MDR Text Key: 338880136
• Report Number: 3007284006-2024-00065
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• 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 6935M RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White