MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

Catalog Number LR-OFA01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Common device name: stylet, catheter.Procode: drb.Pma/510(k): k970690.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.

Event Description

After unsuccessful tle procedure, lead and locking stylet (lr-ofa01) were cut and fixated in patient.Approximately 6 months later; patient complained of pain in shoulder.An x-ray subsequently revealed pieces of unidentified wire located within patient¿s shoulder.The failed extraction of the liberator locking stylet resulted in the tube being capped and failed removal; creating the small possibility that the tube emigrated to its current location.The removed wires are being sent back to for confirmation that they are indeed liberator parts.No parts of device remained in patient¿s body after procedure and no additional procedures took place due to this occurrence.

• Brand Name: LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 11665986
• MDR Text Key: 245418801
• Report Number: 2522007-2021-00015
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• PMA/PMN Number: K970690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

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 Catalogue Number: LR-OFA01
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 22 YR
• Patient Sex: Male