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

Model Number N/A

Device Problem Complete Blockage (1094)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Initial reporter occupation: pharmaceutical.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 was obstructed, preventing a blood pressure reading from being obtained.A (b)(6) year old female patient in postoperative surgery had a catheter placed in the right radial artery in the upper limb.The device was secured to the patient with a catheter butterfly.An arterial pressure monitoring line was attached to the catheter.Imaging was not used to aid in the placement of the device.When performing the sanitization and repositioning of the limb, it was verified that invasive pressure was not being read.Several washing maneuvers were performed to unblock the device but were unsuccessful.It was reported that the device was replaced.Upon removal, no defect of the device was noted.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by andrea santos from agility logistics, brazil that the ¿pressure reading was not happening.¿ the complaint device was reported to be a radial artery pressure monitoring set (rpn: c-pms-400-ra, lot number 13169074).The patient was a 52 year-old female.On (b)(6)2020, while the patient was in the postoperative surgery unit, the radial artery pressure monitoring catheter was inserted into the right radial artery.It was secured to the patient using the ¿fixation on the catheter butterfly.¿ the radial artery pressure monitoring catheter was attached to an arterial pressure monitoring line.While flushing and repositioning on the limb, the pressure reading was not occurring.Several ¿washing maneuvers¿ to the catheter were reported to have been completed to ¿unblock¿ the catheter.The device was removed and replaced.It was reported that upon removal, no defects of the catheter were noted.A review of documentation including the complaint history, device history record and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to assure device integrity and functionality prior to shipment.A review of the device history record (dhr) for lot 13169074 found no related nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The radial artery pressure monitoring set is not supplied with an instructions for use (ifu).Based on the information provided, no returned product and the results of our investigation, it was concluded that the cause could be traced to an unintended use error.The medical procedure itself or patient re-positioning could have contributed to the cause of this event.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.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: 11259575
• MDR Text Key: 229657269
• Report Number: 1820334-2021-00218
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002020924
• UDI-Public: (01)00827002020924(17)230501(10)13169074
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-400-RA
• Device Lot Number: 13169074
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR