MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD #2 LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-019

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

A2): patient''s date of birth unk.A4): patient''s weight unk.D4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be complete.H4): device manufacture date unk because lot number unk.H6): device damage is a known risk of complication 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.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular (rv) leads, one active and one capped, due to redundant lead.Spectranetics lld #2 lead locking devices (lld #2s) were inserted into each lead to provide traction.Multiple spectranetics devices (tightrail sub-c rotating dilator sheath, glidelight laser sheath) were used in the procedure.During the procedure, the active rv and ra leads were successfully removed.Then, using the tightrail sub-c on the capped rv lead, the lld and lead broke outside the patient''s body; therefore, there was no longer a traction platform.A snare was used from the groin, and the capped rv lead and lld remnants were successfully removed.The patient survived the procedure with no reported patient injury.This report captures the lld #2 providing traction within the capped rv lead which broke, requiring intervention.

• Brand Name: LLD #2 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: 18645159
• MDR Text Key: 334616807
• Report Number: 3007284006-2024-00028
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• 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: ABBOTT 7122Q ACTIVE RV PACING LEAD; BOSTON SCIENTIFIC 7740 RA PACING LEAD; BOSTON SCIENTIFIC 7741 CAPPED RV PACING LEAD; SNARE MANUFACTURER/TYPE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LLD #2 LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White