MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

Device Problem Break (1069)

Patient Problems Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth unavailable; patient weight unavailable; relevant testing unavailable; relevant history unavailable.Device evaluation: the device was returned and decontaminated on 03 march 2020 and then evaluated by a cross functional team on 04 march 2020.The lld was found to be broken; the device was returned in two pieces.The device was broken at the core mandrel, 42cm proximal of the distal tip, and distal of the crimped wave feature section.Additional kinks were observed at the location of the break.Additional follow up information from the philips representative informed the manufacturer that a hemostat was used on the lld to provide torque to unscrew the helix of the right ventricle (rv) lead.Historically, philips has seen this failure mode when any stressors have been applied to the device's core mandrel located distal to the crimped wave feature section.Stressors such as a suture, hemostat, or other mechanism, may kink and/or create a weak spot in this area, leading to the core mandrel break.This was determined to be the cause of the experienced failure.

Event Description

Lead extraction case commenced to remove a right ventricle (rv) lead and right atrial (ra) lead due to a non-functioning lead and upgrade.The rv lead was prepared with a spectranetics lead locking device (lld).The philips representative reported that the lld broke during use.At that time, the philips representative reported there was no damage to the device.It was reported that the lld was unlocked, removed from the lead, and replaced with another lld.The second lld was used to remove the rv lead.The procedure was completed, and no patient injury was reported.However, upon device return and evaluation that took place on (b)(6) 2020, the device was found to be broken.This mdr is being submitted due to the potential for serious injury with recurrence.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica dominguez ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9918729
• MDR Text Key: 222065859
• Report Number: 1721279-2020-00076
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)211126(10)FLP19L25A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19L25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 74 YR