MAUDE Adverse Event Report: COOK INC RADIAL ARTERY PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	C-PMS-300-RA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/23/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a patient included in a trial passed away.A cook inc.Radial artery pressure monitoring set was being used in the right radial.There was no cause of death provided.There was no complaint of any device malfunction.There was no information provided suggesting the device caused or contributed to the death.Additional questions have been asked regarding the following and to date there has been no information provided.Please provide cause of patient death? did the complaint device cause or contribute to the death of the patient? what was the device being used for during the procedure? please provide autopsy or pathology reports if available? please provide the patient's condition at the time of device placement? please provide any procedural imaging if available? please provide patient demographics.Please provide patient pre-existing conditions.(please provide any patient pre-dispositions).Please provide any images or videos of complaint device if available?.
Additional Manufacturer Narrative
Additional information: the customer stated on (b)(6) 2018 during a phone conversation that this report was not a device complaint.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7728771
• Report Number: 1820334-2018-02166
• Device Sequence Number: 1451681
• Product Code: DQO
• UDI-Device Identifier: 00827002019089
• UDI-Public: (01)00827002019089(17)200727(10)8099511
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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 Expiration Date: 07/27/2020
• Device Catalogue Number: C-PMS-300-RA
• Device Lot Number: 8099511
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 10/11/2018
• 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: Death