MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-062

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2023

Event Type  Injury  

Manufacturer Narrative

H3): a portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.H6): although device damage is a known risk of complication with use of the lld, the cause for the lld breaking could not be established.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 lead locking device (lld) was inserted into the lead to provide traction.Multiple spectranetics devices (16f glidelight laser sheath, visisheath dilator sheath, 13f tightrail rotating dilator sheath) were used to attempt the extraction; however, due to the severe curvature of the lead, advancement was impossible.A cook medical 13f evolution dilator sheath was used for a last attempt, but could not advance.During this attempt, traction was being placed on the lead using the lld to see if the lead could be freed, and the lead insulation, part of the voltage cables, and a portion of the lld came out of the lead.Due to the fact this was a class 2 indication for removal and the patient wasn't infected, the physician chose to cap the lead with a portion of the lld inside, and abandon it within the patient.The patient survived the procedure.This report captures the lld within the rv lead which was capped and retained in the patient.

• Brand Name: LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 16988644
• MDR Text Key: 315798651
• Report Number: 1721279-2023-00083
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023076
• UDI-Public: (01)00813132023076(17)250228(10)FLP23A30A
• 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: 05/23/2023

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
• Device Lot Number: FLP23A30A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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: BOSTON SCIENTIFIC 0282 RV ICD LEAD; COOK MEDICAL 13F EVOLUTION DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American