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

Model Number N/A

Device Problems Occlusion Within Device (1423); Unable to Obtain Readings (1516)

Patient Problem No Code Available (3191)

Event Date 09/21/2017

Event Type  Injury  

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 the arterial lines of the radial artery pressure monitoring set were dampened and unable to draw blood after being inserted/rewired.The lines were reportedly in place for less than 48 hours, and the accuracy of the lines was limited.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.

Manufacturer Narrative

Pma/510(k) #: preamendment.Investigation - evaluation: a review of the quality control and specifications was conducted during the investigation.Clinical assessment: it is not certain if ¿overdamping¿ or ¿underdamping¿ is occurring.In either case, the accuracy of the systolic and diastolic pressures would be inaccurate.Often, overdamping is more associated with loose connections, air bubbles, kinks, blood clots, arterial spasms or narrow tubing which would be more consistent with the inability to draw blood from the line.In overdamping, there is a sluggish resonance in the system resulting in an underestimated systolic pressure or overestimate diastolic pressure.The (b)(4) contains the p3.0-18-5-w-ns-0 central venous catheter.There is no information regarding the placement of the device or any difficulty with placement that may have contributed to this event.There is no mention of leaking that may have contributed to this event.There is no information regarding securing the device or any environmental issues that may have contributed to this event.There is no information regarding any human anatomy or physiology that may have contributed to this event.At this time, clinical assessment cannot eliminate any possible causes for this event such as placement, user technique, product handling, environmental, maintenance, device failure, or manufacturing related causes.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.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.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.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 Description

The international customer reported that the arterial lines of the radial artery pressure monitoring set were dampened and unable to draw blood after being inserted/rewired.The lines were reportedly in place for less than 48 hours, and the accuracy of the lines was limited.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 clarification: unable to draw blood within 10 hours of insertion.

• 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: 6961537
• MDR Text Key: 89720038
• Report Number: 1820334-2017-03590
• Device Sequence Number: 1
• Product Code: DQO
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 03/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention