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

Model Number 518-019

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

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 during a cardiac lead management procedure to extract a malfunctioning implantable cardioverter defibrillator (icd) lead that the physician prepped the cardiac implantable electronic device (cied) pocket and right ventricular riata icd lead, utilizing a spectranetics lead locking device (lld)#2.There was severe lead on lead binding encountered in the area of the subclavian, innominate, superior vena cava (svc) area.Due to complications which arose during the case, the lead locking device was cut and capped within the 65 right ventricular (rv) riata lead and remains within the patient to date.It was also reported that a perforation had occurred in the right ventricle (rv), presumed to be where the active fixation screw from the rv lead was located.Rescue interventions were implemented and the patient survived the procedure.

• 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: 8425546
• MDR Text Key: 138959760
• Report Number: 1721279-2019-00043
• Device Sequence Number: 1
• Product Code: DRB
• 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: 01/01/2005,02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2020
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC18K18A
• 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: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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
• Treatment: 65 LINOX LEAD; SETROX 67 LEAD; SJM RIATA 168 LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 76