MAUDE Adverse Event Report: COOK VASCULAR INC. LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number LR-EVN-11.0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Information (3190); Pericardial Effusion (3271)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

This specific evolution device is currently not registered for sale in the us.The 510(k) number provided is of a device that is considered 'similar' to other metal biliary stents/sets (evolution) devices currently marketed in the us.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

A lead management case was reported to spectranetics in which an adverse event occurred and a cook evolution was reportedly in use.Date of procedure: (b)(6) 2018.Event was initially reported that a spectranetics tightrail device blade mechanism did not activate.However, additional information was obtained from (b)(6), quality assurance assistant, (b)(6), who spoke with the sales representative.There was no reported harm to the patient due to the tightrail device; however the physician decided to use a cook medical device (evolution) and an adverse event occurred.Additional intervention was needed, which resulted in an open thorax, but case was successfully completed and patient is reportedly recovering from the surgery at home.Spectranetics has no further information on the cook device.

Manufacturer Narrative

The initial mdr for this complaint was submitted on october 4, 2018.Since then it has been determined that the device identified in the initial report is incorrect (catalog # evo-fc-10-11-8-b).The manufacturer of this device is also incorrect.The correct device to which this adverse event can be attributed to is catalog # lr-evn-11.0.This report reflects the necessary corrections regarding the device catalog #.A new initial mdr will be filed regarding this adverse event identifying the correct manufacturer with the manufacturer report # 2522007-2018-00028.Updates: investigation summary: the lr-evn device was not returned and therefore a physical evaluation could not be performed.The lot number was not provided and therefore the device history record could not be performed.The instructions for use was reviewed and listed as a potential adverse event is 'laceration or tearing of vascular structures or the myocardium.' this complaint failure will be monitored per the post market surveillance and complaint handling process.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; tat a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

The initial mdr for this complaint was submitted on october 4, 2018.Since then it has been determined that the device identified in the initial report is incorrect (catalog # evo-fc-10-11-8-b).The manufacturer of this device is also incorrect.The correct device to which this adverse event can be attributed to is catalog # lr-evn-11.0.This report reflects the necessary corrections regarding the device catalog #.A new initial mdr will be filed regarding this adverse event identifying the correct manufacturer with the manufacturer report # 2522007-2018-00028.

• Brand Name: LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK VASCULAR INC.; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7934398
• MDR Text Key: 122802052
• Report Number: 3001845648-2018-00471
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K121430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LR-EVN-11.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2018
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Required Intervention