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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to lead fracture and bacteremia.Imaging confirmed the lead was fractured prior to the procedure.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead, only advancing to the fracture site, and locked to provide traction.Beginning with a spectranetics glidelight laser sheath, progress stalled and was unable to advance past the fracture site.At that time, the lead completely separated into two pieces, and a portion of the lead, glidelight, and lld ez were removed from the patient.For approximately one hour, snaring was attempted to remove the lead remnant; however, efforts were not successful, and the procedure was aborted.The lead necessitated removal due to infection; therefore, the patient was transferred to another facility/physician to continue attempts for removal of the lead remnant.The following day, a snare was being used to retrieve the lead remnant when the patient's blood pressure dropped.A sternotomy was performed and a perforation in the left lower lobe artery was discovered.It was believed that the conductive cable of the rv lead had migrated into the injury location.The repair was successful, and the patient survived the procedure.There were no spectranetics devices in use during this procedure.This report captures the lld which broke the rv lead at the fracture site, requiring intervention - delay of procedure.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A4): patient's weight unk.A5a./5b.): patient's ethnicity/race unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.D4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H6): lead damage is a known risk with use of the lld.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.H4): device manufacture date unk because lot number unk.

• 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: 18763230
• MDR Text Key: 336052473
• Report Number: 3007284006-2024-00039
• 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: 02/22/2024

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?: No
• 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: 02/22/2024
• 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; SNARE MANUFACTURER/TYPE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male