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

Model Number 518-022

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2019

Event Type  Injury  

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 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
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8496747
• MDR Text Key: 141369834
• Report Number: 1721279-2019-00062
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: 00813132023027
• 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: 01/01/2005,03/15/2019

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
• Device Operator: Health Professional
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• 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
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 75