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

Model Number 518-018

Device Problem Break (1069)

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

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's weight unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.The physician chose a spectranetics lead locking device (lld) to act as the traction platform to aid in lead extraction.However, after he had inserted the lld into the lead and attempted to engage the locking mechanism, the lld broke into two pieces.The physician then chose to use a cook medical bulldog lead extender and suture to act as traction platforms instead with no disruption in case flow, and successfully completed the case with no reported patient harm.This report is being submitted due to the potential for serious injury if this event were to recur.

• 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10521147
• MDR Text Key: 238580741
• Report Number: 1721279-2020-00191
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132022990
• UDI-Public: (01)00813132022990(17)220324(10)FLA20C20A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 01/01/2005,08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2022
• Device Model Number: 518-018
• Device Catalogue Number: 518-018
• Device Lot Number: FLA20C20A
• Was Device Available for Evaluation?: No
• 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
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 16 YR