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

Model Number 518-039

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Iatrogenic Source (2498)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth unavailable.Patient weight is unavailable.

Event Description

This report is being submitted for the lead locking device that broke during the procedure, with a potential to cause serious injury with recurrence.A lead extraction procedure commenced to remove 2 leads that had been implanted in 1998: a right atrial (ra) lead and a right ventricular (rv) lead after an unsuccessful attempt at performing a pacemaker generator extrusion due to bacteremia, non function and occlusion; therefore a total system extraction was indicated.Spectranetics devices in use: glidelight, tightrail and lead locking devices (lld''s) placed in each lead.While using the tightrail and glidelight devices, it was reported the physician had difficulty advancing, and reported low efficiency with attempts to advance the glidelight device.It was at that point it was noted that light was escaping from the glidelight device, being covered by the device's outer sheath (please refer to mdr #1721279-2019-00088 which captures the glidelight product problem).A new device was then needed.At this time, the lld, present in the ra lead, broke, necessitating removal of the broken lld (which was successful) and replacement with another lld in the lead.Unfortunately, it was not possible to complete extraction of both electrodes, with the tip of the ra lead and approximately 5 cm of the rv remaining in the patient.The lld''s were successfully removed from both leads and just the leads themselves remained in the patient.No reported injury or harm occurred to the patient.

• 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: 8652424
• MDR Text Key: 152069059
• Report Number: 1721279-2019-00088
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023052
• UDI-Public: (01)20813132023052(17)191031(10)FLJ17K31A
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K043401
• 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: 01/01/2005,05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ17K31A
• 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: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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): Required Intervention
• Patient Age: 51 YR