MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

Catalog Number	LR-NES002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Blood Loss (2597)
Date of Event	05/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name) dre, dilator, vessel, for percutaneous catheterization.(b)(4).Investigation- a review of the complaint history, device history record, instructions for use (ifu) and a visual inspection of images provided was conducted for the purpose of this investigation.The device was not returned to assist with the evaluation.No damage or nonconformity was observed on the device in the returned images, and no signs of nonconformity or misuse were observed on the video from the procedure.Manufacturing records were reviewed, and there are no signs this device contained a nonconformity.No other complaints have been filed for this device lot.The ifu was reviewed, and cardiac tamponade is a documented risk of the pacemaker lead removal procedure.Based upon the information available, the root cause of this complaint is an adverse physiological response by the patient.
Event or Problem Description
During the successful extraction of rv lead with the lead extraction needle's eye femoral snare after 10 min at icu they saw a cardiac tamponade.Punction of pleura and drain up to 2 l blood during 3 hours.Intubation of patient again and moved to hyprid kath lab/or.The heart surgeon was in standby for thoracotomy, but after 3 hours a few thrombin was seen and the bleeding stopped.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5748280
• Report Number: 1820334-2016-00496
• Device Sequence Number: 16299247
• Product Code: DXE
• UDI-Device Identifier: 00827002265158
• UDI-Public: (01)00827002265158(17)190131(10)N134779
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2016

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-NES002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2016
• Initial Report FDA Received Date: 06/24/2016
• 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: Life Threatening; Required Intervention
• Patient Age: 38 YR