MAUDE Adverse Event Report: COOK INC SINGLE LUMEN DISTAL AORTIC PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(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

The international customer reported that, in order for the single lumen distal aortic pressure monitoring set to work correctly, "additional traction" [sic] had to be added.The bedside nurse questioned the accuracy of the arterial line blood pressure.No adverse events were reported by the customer.According to the form provided by the customer, "product reached patient; no apparent harm; probably inconvenient for patient and/or staff." additional information has been requested from the customer, but none has yet been provided.It is unknown is the device is available for return; as of the date of this report, no device has yet been received for evaluation.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, documentation, device history record, specifications, trends, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.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.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.

• Brand Name: SINGLE LUMEN DISTAL AORTIC PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7283397
• MDR Text Key: 100671030
• Report Number: 1820334-2018-00494
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002059481
• UDI-Public: (01)00827002059481(17)201009(10)8278034
• 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: 06/18/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-501J-DAP-PKG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1