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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
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.
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.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key7211326
MDR Text Key106278320
Report Number1820334-2018-00049
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002089570
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberG08957
Device Catalogue NumberRCFW-14.0-38-30-RB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/22/2018 Patient Sequence Number: 1