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

Model Number	518-039
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Iatrogenic Source (2498)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth unavailable.Patient weight is unavailable.
Event or Problem 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
• Common Device Name: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8652424
• Report Number: 1721279-2019-00088
• Device Sequence Number: 2129862
• Product Code: DRB
• UDI-Device Identifier: 20813132023052
• UDI-Public: (01)20813132023052(17)191031(10)FLJ17K31A
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K043401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005