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 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Patient's date of birth unavailable.Patient's weight unavailable.Device evaluation: the device was returned on 09 dec 2019 and evaluated on 11 dec 2019 by a cross functional engineering team.A portion of the lld was returned and complaint was confirmed.The device was broken 4 cm proximal of the proximal taper of the device, which is where the locking feature of the device is located.The cause of the break cannot be determined.

Event Description

A lead extraction procedure commenced in order to remove one lead: a right ventricular (rv) lead due to a planned upgrade to a crt-d system.A spectranetics glidelight laser sheath and a cook medical bulldog device were used to successfully remove the rv lead.A right atrial (ra) lead was present within the patient and was at first not targeted for removal, but physician chose to remove it after the rv lead was extracted.The glidelight laser sheath and a lead locking device (lld) were used to attempt removal of the ra lead.During the extraction, the tip of the ra lead released but the lead body was stuck within the vasculature.The physician applied traction to the tip of the ra lead using a snare and lld; the physician lased in the area of the superior vena cava (svc) but at that time the lld broke.The physician utilized a cook bulldog device and the remaining portion of the lld and the ra lead were removed successfully with no reported patient harm.This report is being submitted due to the potential for serious injury if the event were to recur.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9460295
• MDR Text Key: 194397660
• Report Number: 1721279-2019-00214
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)210501(10)FLP19E01A
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19E01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• 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: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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: 71 YR