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

Catalog Number C-PMS-401J-FA

Device Problem Kinked (1339)

Patient Problem Death (1802)

Event Date 05/05/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

According to the initial reporter, the patient was very unstable.He was persistently hypotensive, required multiple pressors, and unfortunately, the patient ultimately passed away.Respiratory therapy initially attempted to place a radial arterial line but his blood pressure did not permit adequate localization.Both health professionals on duty attempted to place a femoral arterial line as monitoring of continuous blood pressure was deemed appropriate for this patient.In both cases, the kit was clearly inadequate, the guidewire kinked upon entry into the artery, and despite numerous attempts including ultrasound guidance, we were unable to successfully establish an arterial line.1st attempt was radial a-line by respiratory therapist.2nd and 3rd attempt was a femoral a-line by health care professionals.Persistently hypotensive, required multiple pressors, and unfortunately, he ultimately passed away.

Manufacturer Narrative

Investigation - evaluation.A review of the complaint history, drawings, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.It is not clear if the root cause of the event is associated with patient condition (persistently hypotensive), procedure (difficult entry into the line), or eventual malfunction of the device (kinked).Based on clinical assessment, review of customer statements, and the lack of a returned complaint device; we are unable to draw a conclusion as to the root cause of the event or how it led to the outcome of patient death in this case.It is possible that the patient's condition was a significant contributing factor based on the customer statement.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

Event Description

It was reported that this patient was very unstable.He was persistently hypotensive, required multiple pressors, and he ultimately passed away.Respiratory therapy initially attempted to place a radial arterial line (a-line), but his blood pressure did not permit adequate localization.Both health professionals on duty tried to place a femoral arterial line as monitoring of continuous blood pressure was deemed appropriate for this patient.In both cases, the kit was clearly inadequate; the guidewire kinked upon entry into the artery and despite numerous attempts including ultrasound guidance, they were unable to successfully establish an arterial line.The first attempt was radial a-line by respiratory therapist.The second and third attempts were femoral a-line by health care professionals.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5754684
• MDR Text Key: 48307547
• Report Number: 1820334-2016-00494
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: C-PMS-401J-FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/05/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 08/22/2017
• 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