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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: not exempt, pre-amendment.(b)(4).Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of quality control data, specifications, and trends.One device returned to manufacturer for investigation.The device was returned severed 1 mm from the hub of the tubing.Visual examination noted the tubing is smashed and bent.The remaining severed segment measures 4.7 cm in length.A review of the device history record (dhr) could not be performed due to the lack of lot information available from the user facility.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 complaint was confirmed based on the returned device.A definitive conclusion for the failure mode could not be established.However, considering the smashed & bent tubing ¿ it can be suggested that unintended use error could have contributed to this event.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Event Description

It was reported, a 2.5fr/5cm arterial line from the radial artery pressure monitoring set was retrieved from a (b)(6) child.The radial artery pressure monitoring set catheter had broken off a few millimeters from the hub.It required a return to the or under general anesthesia and open arteriotomy to retrieve 4.6cm of the catheter.The patient¿s hand is ok and ligation of the artery was not needed.The child is doing well.In additional information received from the facility, it was reported that the catheter was visually inspected and it appeared intact prior to placement.Ultrasound guidance was utilized and placement was achieved on the first attempt with no difficulties whatsoever.The catheter was secured with a stitch around each phalange and also one around the hub.The suture around the hub was in the groove, not around the actual catheter itself.The nurse reported that there was nothing difficult or unusual about the removal of the device.The sutures were cut and pressure was held as the line was removed (described as simultaneous).The site had been bleeding and oozing throughout the day.

• 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8565675
• MDR Text Key: 143583664
• Report Number: 1820334-2019-01055
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-250-RA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR