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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
No new event description information to report at this time.
Additional 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
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7283397
• Report Number: 1820334-2018-00494
• Device Sequence Number: 16173765
• Product Code: DQO
• UDI-Device Identifier: 00827002059481
• UDI-Public: (01)00827002059481(17)201009(10)8278034
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-501J-DAP-PKG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1