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

Model Number N/A

Device Problems Difficult to Flush (1251); Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2017

Event Type  malfunction  

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, when the radial artery pressure monitoring set was employed, the waveform dampened immediately following insertion.Flushing and wrist repositioning improved the signal, but 48 hours post insertion, the waveform was ultimately completely absent, and flushing was difficult.The blood draw had become slow, and significant pressure was required at the insertion site.The waveform was again absent at the 54 hour post insertion.Flushing and blood draw became impossible.Additional information has been requested from the customer, but has not yet been provided.The device is reportedly available for return and investigation; 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.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.As described in the description of problem it was placed in the radial artline in the wrist did any section of the device remain inside the patient¿s body? no ¿ question is not relevant to this problems description.Did the patient require any additional procedures due to this occurrence? no ¿ question is not relevant to this problem did the event result in a death? no.Investigation ¿ evaluation: a review of the complaint history, device history record, 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 record found no other non-conformances associated with the complaint device lot number; 7970203.Additionally, a review of the manufacturer's complaint database found no other complaints associated with the complaint device lot number; 7970203.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: 7088670
• MDR Text Key: 94218009
• Report Number: 1820334-2017-04164
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002019089
• UDI-Public: (01)00827002019089(17)200606(10)7970203
• 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: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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