MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET; DQX WIRE, GUIDE, CATHETER

Catalog Number	LR-OFA01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation- a review of the complaint history and device history record was conducted for the purpose of this investigation.No device was returned to assist with the investigation.Based on the description of the event, the liberator was not deployed and locked when the event occurred.There are no signs that a device was at the location of the tear, exerted force to cause the tear, malfunctioned, or was misused.Without the device or more information, a full investigation cannot be performed.Warnings, risks of the procedure, and potential adverse events are documented in the device's ifu.There are no signs that the device was not manufactured to specifications or performed outside its designed characteristics.Based on the information provided, no cook devices were at the location of the tear in the vasculature, and the root cause appears to be related to the condition of the patient or the lead.
Event or Problem Description
Physician placed the liberator locking stylet down the pacemaker lead.The locking stylet went half way down and was not able to be advance further.The doctor started to place the 11fr evolution over the pacemaker lead when the lead pulled back and was free.The adhesion on the pacemaker lead pulled a hole in the heart muscle that cause a rip.The doctor then started to open the patient chest to repair the rip.A section of the device did not remain inside the patient's body.No additional adverse effects have been reported.

• Brand Name: LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5553776
• Report Number: 1820334-2016-00223
• Device Sequence Number: 16220512
• Product Code: DQX
• UDI-Device Identifier: 00827002265509
• UDI-Public: (01)00827002265509(17)170228(10)N118999
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K970690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: LR-OFA01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2016
• Device Age: 2 YR
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2016
• Initial Report FDA Received Date: 04/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 79