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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 03/20/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter: customer (person): street: - (b)(6).Reporter occupation: administrative supervisor.Report source - other: mw (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 Description

It was reported that the catheter of a radial artery pressure monitoring set broke, leading to an intervention to remove a portion of the device left behind in the patient.A (b)(6) year old male patient underwent a procedure in which the radial artery pressure monitoring set was used.The catheter snapped while dressing was being removed on the patient's arterial line.Staff were unable remove the device due to bleeding from the site.Pressure was held to the site and a stat us was ordered to visualize the catheter.The or was then booked for exploratory surgery in order to remove the catheter.The right hand remained warm with good capillary refill and pulse.The surgeon was able to retrieve the catheter at bedside.Additional information regarding event details and patient outcome have been requested, but is currently unavailable.

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

In additional information received on 21apr2021, it was reported that the patient is "doing ok" after beside removal by the vascular surgeon.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d9 - returned to manufacturer on, d10 - concomitant products: cook device returned with competitor's extension tubing attached.Investigation ¿ evaluation.It was reported by (b)(6) , vice president of legal affairs for (b)(6) hospital, usa via a medwatch form 3500a, that an arterial catheter separated.The patient was reported to be a 39-year-old male at the time of the event.On (b)(6) 2021, while the dressing was being removed from the patient¿s arterial line, the arterial line separated.The separated portion of the catheter remaining in the patient was unable to be retrieved by the provider who was removing the dressing.Pressure was held to the site after the catheter separation.An ultrasound was ordered immediately, and the catheter was visualized.The operating room was scheduled for exploratory surgery to remove the catheter.The patient¿s right hand remained warm with good capillary refill and pulse.A vascular surgeon was able to retrieve the catheter at the bedside.The patient was reported to be doing ¿okay¿ after the event.Reviews of documentation including the complaint history, device history record (dhr), quality control, as well as a visual inspection of the returned device were conducted during the investigation.One used radial artery pressure catheter returned to the manufacturer for evaluation with a competitors extension tubing attached to the catheter.The catheter separated in a short section beyond the hub.The lumen of the catheter shaft attached to the hub appeared to be flattened.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 dhr for the reported complaint device lot and component lot revealed no non-conformances relevant to the failure mode.A database search found no other complaints have been reported for the complaint lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event could not be established.A clinical assessment of the complaint was unable to rule out care and maintenance of the device, or inadvertent tension placed on the device as a cause of the event.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.

Event Description

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

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11684761
• MDR Text Key: 246853511
• Report Number: 1820334-2021-01151
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002019089
• UDI-Public: (01)00827002019089(17)231213(10)13626746
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2023
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-300-RA
• Device Lot Number: 13626746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2020
• 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
• Treatment: UNKNOWN MANUFACTURER EXTENSION TUBING
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR