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

Model Number 518-019

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

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

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

Device not returned as part of the device remains implanted in patient and the rest of the device was discarded by the site.Further evaluation not possible.No allegation of a malfunction of a spectranetics device.The physician has been notified that the lld device is not intended for permanent implantation.

Event Description

A philips representative reported that during a cardiac lead management procedure on (b)(6) 2018, 3 leads were planned to be removed.Two right ventricular (rv) leads and one right atrial (ra) lead.The first rv lead was successfully removed.Significant fibrosis was identified in several areas and lead on lead binding was confirmed in the area of the innominate/superior vena cava (svc), both proximal and distal to the svc coil.The physician attempted to remove the other two leads utilizing various spectranetics devices, but was unsuccessful.The remaining ra lead began to break apart and unravel during the extraction attempt.Then, multiple attempts were made to advance enough to remove the remaining rv lead, but the physician was unable to do so.There was too much calcium in the area of the superior vena cava (svc) to advance through.As a result, the physician decided to abandon the procedure after multiple attempts to extract the leads.He capped the remaining ra lead.He then cut the proximal end of the spectranetics lead locking device (lld) 518-019 and capped the remaining length of lld and the rv lead, securing both leads in the pocket.The remaining length of the lld (from the pocket distal to the tip) remains inside the rv lead, cut and capped within the patient.The patient has since made a full recovery and is expected to receive a subcutaneous icd system at a later date.

• Brand Name: SEPCTRANETICS 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: 7949904
• MDR Text Key: 123194855
• Report Number: 1721279-2018-00146
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• 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: 01/01/2005,09/20/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2020
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC18B16A
• 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: 09/20/2018
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 86