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

Model Number	N/A
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The international customer reported that the arterial lines in the radial artery pressure monitoring set clotted.The circumstances surrounding the usage and handling of the devices leading up to the reported clotting were not reported.Additional information has been requested from the customer.The product is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Pma/510(k) #:preamendment.Investigation ¿ evaluation: a review of the complaint history, device history record , quality control, and specifications were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.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 review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted 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, however; based on the provided information the likely root cause is deemed to be; ¿inconclusive¿.We will continue to monitor similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The international customer reported that the arterial lines in the radial artery pressure monitoring set clotted.The circumstances surrounding the usage and handling of the devices leading up to the reported clotting were not reported.Additional information has been requested from the customer.The product is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.After further review of the record, it was determined that it should be noted that 2 devices from the same lot were reported with this event.Additional information has been requested for additional clarification.However, none has been received to date.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6960858
• Report Number: 1820334-2017-03589
• Device Sequence Number: 1325279
• Product Code: DQO
• UDI-Device Identifier: 00827002019089
• UDI-Public: (01)00827002019089(17)200629(10)8030201
• 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): 04/03/2018

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-300-RA
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 04/03/2018
• Patient Sequence Number: 1