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

Model Number N/A

Device Problems Flushing Problem (1252); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

Pma 510k status: preamendment.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The international customer reported that the arterial line of the radial artery pressure monitoring set was not functioning correctly less than 24 hours after insertion of the line.Blood could not be drawn, the line could not be flushed, and accurate waveforms could not be obtained.Attempts to rewire and re-insert the device were necessitated.The blood pressure measurements were reported to be less accurate.Additional information has been requested from the customer, but none has yet been provided.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.

Manufacturer Narrative

Previously requested additional information was received from the customer.Please describe the actions taken in response to this event.Could the product be used successfully? only for the first 24 hours.What types of fluids were being infused through the line? heparinized saline.What is the maintenance protocol for the catheter? heparinized saline under pressure to flow at 3mls/hr.Can patient demographics be provided? no ¿ reason is foip.Please describe the other products and equipment used during the procedure (endoscope type and model, introducer, wire guide, etc.) standard stylet that comes with the catheter to assist with insertion.Did the patient have a pre-existing condition and/or pre-diagnosis relevant to this event? no.Please describe the placement site for this procedure.Radial artline in the wrist did any section of the device remain inside the patient¿s body? no.Did the patient require any additional procedures due to this occurrence? no ¿ question is not relevant to this problems description.Did the event result in a death? no.Please specify adverse effect(s) and provide details: patient required second artline placement in other wrist.Investigation ¿ evaluation: a review of the documentation and quality control data of the device was conducted during the investigation no complaint device has been returned for investigation.No photos have been provided.However, a documentation investigation/evaluation was conducted.A review of the device history cannot be completed at this time as there was no lot number was provided.Additionally, a review of the manufacturer's complaint database cannot be completed at this time as there was no lot number was provided.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A definitive root cause could not be determined, however; based on the provided information the likely root cause is deemed to be; ¿inconclusive¿.Per the quality engineering risk assessment no further action is required.We will continue to monitor similar complaints and have notified the appropriate personnel of this event.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7097904
• MDR Text Key: 94171327
• Report Number: 1820334-2017-04316
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-300-RA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• 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