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

Model Number 518-062

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight unavailable.

Event Description

During a lead extraction procedure, a spectranetics lld device was being used within a right atrial lead as a traction platform.As the physician was applying moderate traction to the device, the lld broke, outside the patient, at the distal end of the locking mechanism.At that point, another device was used for successful lead removal.There was no reported patient harm and the patient survived the procedure.This report is being submitted due to potential for serious injury or death if this event were to recur.The area where the device reportedly broke could potentially be within a patient's vasculature during a future procedure.

Manufacturer Narrative

D10): device now available for evaluation.H6): method, results and conclusions codes now populated after device evaluation.Device evaluation: device was evaluated on 16 august 2018.Two pieces of the lld were returned.The device is broken.Microscopic inspection revealed a clean break at the core mandrel; break in the taper is consistent with excessive pulling.Braid ends appear cut; and not all of device braid is included in return.The tip of device and majority of device braid is missing.From the evaluation, it is determined that the main failure occurred at the device''s core mandrel.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7764225
• MDR Text Key: 116920409
• Report Number: 1721279-2018-00102
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/18/2018

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: 04/24/2020
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP18D23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• 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: 07/18/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO CONCOMITANT DEVICES LISTED IN REPORT
• Patient Outcome(s): Other
• Patient Age: 53 YR