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

Model Number	518-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.While attempting to remove the ra lead with a spectranetics 16f glidelight laser sheath with its outer sheath, four attempts at advancement occurred through the patient's superior vena cava (svc) region before the patient's blood pressure dropped.Rescue efforts commenced immediately, including rescue balloon, pericardiocentesis, and sternotomy.Perforations were discovered in the svc (mdr #1721279-2023-00028) and the rv and were repaired.The physician believed that over the years, the ra lead migrated extravascular within the svc, as observed during the repair.The rv perforation occurred during the pericardiocentesis, unrelated to any spectranetics device.The ra and rv leads were not removed.The physician did not attempt to unlock either lld prior to cutting and capping the llds within the leads; both leads/llds remained within the patient (this report for ra lead/lld, mdr #1721279-2023-00030 for rv lead/lld).The patient survived the procedure, recovered, and will be re-operated in surgery at a later date for the total lead extraction.This event captures the lld within the ra 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.
Additional Manufacturer Narrative
Patient's date of birth, age unk.Patient's weight unk.Other relevant history unk.A portion of the device was discarded, and a portion remained in the patient; thus no investigation could be completed.Although lld cut/cap is a known risk of complication with the lld, the physician did not attempt to unlock the lld from the ra 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.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: 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 ; 719447-2465
• MDR Report Key: 16461097
• Report Number: 1721279-2023-00029
• Device Sequence Number: 20473222
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: (01)00813132023027(17)240318(10)FLD22A28A
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K990713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• Device Lot Number: FLD22A28A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC 5086 RA PACING LEAD; MEDTRONIC 5086 RV PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White