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

Model Number	518-022
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device lot# could not be obtained.Device expiration date is unavailable as it is determined by lot#.Device manufacture date is determined by lot# and therefore, unavailable.Device remains within patient.Therefore, no device evaluation will be performed.Instructions for use for this device state: warning: excessive applied traction forces may impact the lld¿s ability to disengage from a lead.
Event or Problem Description
A philips representative reported that a cardiac lead management procedure commenced to remove 4 non-functional leads.2 right ventricular (rv), 1 left ventricular (lv) and 1 right atrial (ra) were intended for removal.A spectranetics lead locking device (lld) #2 was inserted to facilitate atrial lead extraction.During the procedure a vessel perforation occurred, rescue interventions were implemented and the patient was stabilized (see mdr 1721279-2019-00029 for further detail regarding vessel perforation).No leads were able to be removed.However, new rv and ra leads were successfully implanted.The physician cut the lld, and a portion of the lld remained in the lead when it was cut.

• 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: 8496747
• Report Number: 1721279-2019-00062
• Device Sequence Number: 11076052
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: 00813132023027
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K990713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• 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: 03/15/2019
• Initial Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC LEAD MODEL #4543; BOSTON SCIENTIFIC LEAD MODEL# 0185; LEAD MODEL #ZY44 (MFR UNKNOWN); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; ST. JUDE LEAD MODEL #1240 6T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 75
• Date Report Sent to FDA: 01/01/2005