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

Model Number 518-062

Device Problem Break (1069)

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

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was not returned to the manufacturer, therefore no investigation could be completed.

Event Description

A lead extraction procedure commenced to extract a capped right atrial (ra) lead, an active ra lead and a right ventricular lead.The patient was having the system upgraded to a bi-ventricular icd system.A spectranetics lead locking device (lld) was used as a traction platform, along with a cook medical one-tie compression coil which was tied to the lead as well.A spectranetics glidelight laser sheath was also in use during the procedure to aid in lead extraction.During the procedure, a lead and lld broke on the lead's proximal end.The physician could not determine which lead broke due to attempting removal of multiple leads.The lead was still adhered to spots within the vasculature that had to be freed in order to extract the lead, but extraction was successful with the aid of a cook medical bulldog lead extender.All leads were successfully extracted and the procedure was completed with no reported patient harm.It is unknown whether the cook medical one-tie device caused or contributed to the lead/lld breaking.This report captures the lld which broke inside one of the leads, requiring intervention.

Manufacturer Narrative

D9): the device was returned to the manufacturer on 21 dec 2021.G3): the device evaluation and investigation were completed on 13 jan 2022.H3): device evaluation: the device was returned and evaluated by a cross functional team.The distal tip of the lld was not returned.The returned portion extends 50 cm from the distal end of the distal loop to the area of the device breakage.Additionally, a kink is present 30 cm from the distal end of the distal loop.There appears to be tool marks near the broken portion of the device, and the device''s mandrel appears crushed and thin near the tool marks, indicating use of a hemostat or other device that had clamped down onto the device in that area.Using a scanned electron microscope, the images showed damage on one side of the device and then under tension, the damaged area broke.The damaged side had striations indicating it was damaged by a hemostat or other device.The remainder of the device portion had pitted and stretched damage, indicating the device was stretched past its tensile strength by the user.This has been determined to be a use related failure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12824201
• MDR Text Key: 282987255
• Report Number: 1721279-2021-00221
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)221217(10)FLP20M15A
• 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,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20M15A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• 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: COOK MEDICAL ONE-TIE COMPRESSION COIL.; MEDTRONIC 4068 CAPPED RA PACING LEAD.; MEDTRONIC 4076 RA PACING LEAD.; MEDTRONIC 5024M RV PACING LEAD.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LEAD LOCKING DEVICE.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male