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

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

(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 signal of the arterial line of the radial artery pressure monitoring set began to be dampened to a point that the waveform no longer correlated to the patient's nominal blood pressure.The operator was eventually also unable to draw blood from the arterial line, although a flush with saline was still possible.The patient reportedly will require another arterial line.Further information has been requested from the customer, but none has yet been provided.The device is reportedly unavailable for return and evaluation.

Manufacturer Narrative

Previously requested additional information was received from the customer.Are there any photos, operating reports, imaging, etc.Available for analysis? no ¿ question is not relevant to this problems description.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.Clinical assessment: there is no information regarding whether the systolic pressure was overestimated or underestimated which would indicate whether over-damping or under-damping occurred.Determining if over-damping or under-damping was the issue could narrow down the root cause.Over-damping is usually caused by loose connections, air bubbles, kinks, clots, narrow tubing, arterial spasms.Under-damping could be a result of catheter whip, stiff non-compliant tubing, tachycardia or hypothermia.At this time, clinical assessment cannot eliminate any possible causes for this event such as device monitoring, device placement, patient condition, device failure, or manufacturing related causes.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.This complaint is confirmed based on the customer's testimony.Based on the provided information a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.

• 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
• MDR Report Key: 7089136
• MDR Text Key: 94052607
• Report Number: 1820334-2017-04317
• 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
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 02/15/2018
• Supplement Dates FDA Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention