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

Model Number 518-062

Device Problem Difficult to Remove (1528)

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

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

Lead locking device remains within the lead, within the patient.Therefore, evaluation is not possible.

Event Description

A philips representative reported that during a cardiac lead management procedure to remove a redundant right ventricular pacing lead and upgrade the cardiac resynchronization therapy defibrillator (crt-d), the physician attempted to remove the lead utilizing a spectranetics lead locking device (lld) 518-062.The physician was unable to remove the lead and decided to leave it.He attempted to unlock the lld, but could not unlock it, so he cut the back portion of the lead extending from the pocket and capped the remaining portion with the lld inside of the lead.He then added the new implantable cardioverter defibrillator (icd) lead and closed the pocket with all inside.No harm to patient.Lead locking device is secured within the lead.

• 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: 8343891
• MDR Text Key: 136279941
• Report Number: 1721279-2019-00021
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 01/01/2005,01/22/2019

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 Expiration Date: 09/07/2020
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP18J06A
• 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: 01/22/2019
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 71