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

Model Number N/A

Device Problem Separation Problem (4043)

Patient Problem No Code Available (3191)

Event Date 01/09/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a radial artery pressure monitoring catheter separated at the hub.A (b)(6) year old patient with septic shock and meningomyelocele underwent a left radial arterial cannulation with the 3 french cook pressure monitoring catheter.One to two hours after placement, the bedside nurse noticed the catheter was leaking.Upon further examination, it was noticed the device was fractured at the point where the catheter inserts into the hub.A hemostat was used to grab the catheter shaft so it didn't lodge into the patient's artery, as it was completely separated from the hub.No unintended section of the device remained in the patient's body.Instead of placing another catheter, the patient had non-invasive blood pressure monitoring and blood was drawn from a central line.Additional information has been requested regarding event information but is not currently available.

Event Description

In additional information received on 01feb2021, it was reported that the device was sutured to the patient, followed by the application of a standard sterile dressing.The patient did not move, as they were sedated with paralytic.There was no difficulty attaching or disconnecting ancillary devices.The issue was noted within 60 minutes of placing the cannula in the patient.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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; that 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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation: it was reported by joseph d.Tobias, md from children¿s hospital, columbus, ohio that the catheter of a radial artery pressure monitoring set (rpn: c-pms-301-ra) separated from the hub.The 19-year-old patient had pre-existing conditions including septic shock and meningomyelocele.The device was placed when the patient was in the pediatric intensive care unit.It was sutured to the patient and a standard dressing was applied.The patient was sedated with ta paralytic.No difficulties were reported with attaching or disconnecting ancillary devices to the catheter.Within 60 minutes of placement, the bedside nurse noted that the catheter was leaking.Upon examination, it was discovered that the catheter had separated at the junction of the hub.The care provider stated that they were able to place a clamp on the shaft of the catheter after it cracked and separated from the hub to prevent the catheter lumen from being left in the patient.The catheter was removed.The patient was monitored with non-invasive blood pressure monitoring.Blood was drawn from a central line.A review of the complaint history, instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One radial artery pressure monitoring set was returned to cook for evaluation.Upon visual inspection, the device was noted to be in two segments with the catheter lumen separated from the hub.The tip near the clear wing fitting was sheared.One of the green catheter tips is severely smashed and the catheter appears to have been stretched.A partial piece of green catheter can be viewed within the hub.Competitor's clear extension tubing was connected to the hub.The catheter lumen had marks indicating where the hemostat was applied to prevent the catheter from entering the patient¿s vessel upon removal.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Given the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.This device is not supplied with an ifu.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive root cause was unable to be established.Inadvertent pressure/tension may have been applied to the device by the provider during care of the patient when performing repositioning or activities of daily living, resulting in device failure.It is also possible that when securing the hub to accessory devices, the securement may have been overtightened, creating a tight fitting and forcing the caregiver to use an instrument (i.E.Hemostats) to disconnect the tubing from the hub.This force can create excessive tension on the junction between the hub and the catheter lumen, contributing to the failure.However, without additional information, these scenarios cannot be confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11253220
• MDR Text Key: 231320413
• Report Number: 1820334-2021-00209
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-301-RA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 19 YR