MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number G08957

Device Problem Split (2537)

Patient Problems Death (1802); Blood Loss (2597); No Code Available (3191)

Event Date 12/22/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The 510k preamendment device.Preliminary investigation: the device history record for the (b)(4), set lot 8204919 was reviewed and no nonconformances were noted.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

On (b)(6) 2018, a complaint from (b)(6) medical center was reported involving a patient who had suffered a stemi and had a total occlusion of the right coronary artery (rca).In response to the patient's compromised cardiac function, a 14 french cook performer introducer was placed in the right femoral artery and used to support the placement of an impella device.It was then reported that the sheath became "crimped," resulting in ¿massive blood loss." the patient subsequently expired after a surgical attempt to correct the problem.On 09jan2018, a conversation occurred with the risk manager (rm) from the user facility and representatives from cook.Per the rm, shortly after placing the cook performer introducer and the impella device, bleeding was observed from the patient and continued over the course of two days.The patient was provided fluids and blood product in response to the bleeding.As the bleeding continued, the patient was taken for surgery to have the impella device removed.During removal of the impella device, the cook sheath was observed to be "cracked." the rm stated the patient's blood loss continued throughout the course of the surgery, resulting in their demise.Following the conversation, the rm faxed a copy of the user facility report with the uf report number (b)(4).The user facility report sent by the facility on (b)(6) 2018, further stated: "patient in cardiac arrest urgently treated for total occlusion of rca with percutaneous intervention.Patient's condition declined and impella placement placed in right femoral artery to support cardiac output.A cook sheath was used to support the impella insertion and management.Patient had a loss of blood volume over the next 24-36 hours.The patient returned to surgery to find the source of bleeding and to remove the impella device.Upon removal of the cook sheath, there was a crack across the tubing." on 09jan2018, additional questions were provided to the rm in attempt to gather more details of the event and devices that were used.On 18jan2018, after following up with the rm, cook representatives were informed that they would not be provided any further details at this time.It was reported that the devices were not retained throughout the course of events, therefore they are not available for further evaluation and investigation.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), and quality control of the device was conducted during the investigation.Additionally, follow up information was requested of personnel associated with the case as part of the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: PERFORMER INTRODUCER
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7211326
• MDR Text Key: 97941372
• Report Number: 1820334-2018-00049
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002089570
• UDI-Public: (01)00827002089570(17)200926(10)8204919
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G08957
• Device Catalogue Number: RCFW-14.0-38-30-RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2018
• Date Device Manufactured: 09/26/2017
• 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): Death; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 92