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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/07/2017
Type of Reportable Event	Serious Injury
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
International customer reported that a patient underwent placement of a radial artery pressure monitoring catheter on (b)(6) 2017 via a left radial artery puncture route.Radial artery pressure monitoring through the device was lost on (b)(6) 2017; one day following placement of the device and initiation of monitoring.It is opined that the device was explanted and a replacement arterial monitoring catheter was placed.No further information was provided.The device is not available for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, drawing, manufacturing instructions, and quality control was completed during this investigation.The device history record was reviewed no non-conformances were noted.The complaint history search revealed this complaint and two other related complaints (b)(4) and (b)(4) associated to the complaint lot number 6968820.These are all from the same user facility and (b)(4) & (b)(4) previously captured 2 failure modes.Without visual, dimensional, and/or functional testing of the product, we are unable to determine with certainty what led to this failure mode.It is feasible that patient condition along with user technique and placement of the device contributed to the loss of blood flow.Based on the available information it is not clear if the leading cause to this event might be associated with a pre-existing patient condition, the medical procedure, or an eventual malfunction of the device.Therefore, the actual root cause is inconclusive.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: 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: 6489558
• Report Number: 1820334-2017-00647
• Device Sequence Number: 1201645
• Product Code: DQO
• UDI-Device Identifier: 00827002020924
• UDI-Public: (01)00827002020924(17)190614(10)7044437
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-400-RA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: 10/07/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention