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); Device Embedded In Tissue or Plaque (3165)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was not provided by the facility.The device was cut/capped inside the lead and remains inside the patient.Therefore it is unavailable for evaluation.The 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 case to extract 3 occluded implantable cardioverter defibrillator (icd) leads, the physician prepped 3 leads for removal, right atrial (ra) and 2 right ventricle (rv) leads utilizing spectranetics lead locking device (lld).After attempts with multiple tools the physician decided to abandon the extraction procedure.The physician was unable to remove the llds from the leads.He decided to cut the back portion of the llds off all 3 leads and capped them.He then closed the pocket.

• 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: 8203142
• MDR Text Key: 131626466
• Report Number: 1721279-2018-00182
• 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: 01/01/2005,12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC18J26A
• 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: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR