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

Model Number N/A

Device Problem Separation Problem (4043)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Occupation: patient safety coordinator.Pma/510(k): preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a cook femoral artery pressure monitoring set broke at the hub, and the distal aspect of the line remained in the patient's femoral artery.A (b)(6) old female patient, confirmed to be covid-19 positive, had a femoral artery pressure monitoring set implanted for arterial blood gas (abg) and pressure monitoring.The physician placed and was suturing the line to anchor it to the skin when the catheter broke at the hub and completely separated into two pieces, with the distal aspect of the line remaining in the patient's femoral artery.The patient was not stable enough to transfer to the operating room to explant the catheter, so a plan was made to remove the device when the patient stabilized or if limb endangerment occurred.The patient ultimately passed away with the catheter still inside them.At this time cause of death is unknown, however it is not suspected to be caused or contributed to by the device.No autopsy was performed.Per the user facility, no additional information regarding this event is available.

Event Description

The event occurred in the hospital in the critical care unit.

Manufacturer Narrative

B3: event date: the customer indicated to be "sometime in (b)(6) 2020.".B5: event description- location of event.B7: additional description of patient.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation ¿ evaluation: as reported, a cook femoral artery pressure monitoring set (part number c-pms-401j-fa, lot number 10333348) separated at the hub, leaving the distal aspect of the line in the 66 year-old female patient¿s femoral artery.The patient was reportedly in the critical care unit and was positive for covid-19.The complaint device was intended to be used for arterial blood gas (abg) and pressure monitoring.After placement, as the physician was suturing the line to anchor it to the skin, the catheter ¿broke¿ at the hub, separating into two pieces.The distal portion of the line remained in the patient's femoral artery, as the patient was not stable enough to transfer to the operating room to remove the catheter.A plan was made to remove the device when the patient stabilized or if limb endangerment occurred.The patient ultimately passed away with the catheter still in the femoral artery.The cause of death is unknown as an autopsy was not performed.Additional information will not be provided.A review of the complaint history, device history record, and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation.A document-based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the device history record found no related nonconformances or additional complaints associated with this device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.The femoral artery pressure monitoring set is not supplied with instructions for use; therefore, a review of the product labeling could not be completed.Based on the information provided, no inspection of the product, and the results of the investigation, a definitive cause for failure was not established.With current, limited information, causes for the event including user technique/procedural issues, manufacturing issues, and/or device failure cannot be ruled out.It is unclear if the shaft completely pulled out of the hub, or if the shaft itself separated at the level of the hub.It is unknown if the user experienced any difficulty placing the device in the patient.Because the separation occurred as the user attempted to suture the line to the patient, it is possible that manipulation of the device may have contributed to the separation.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional patient/event information has been received since the previous medwatch report was sent.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10207360
• MDR Text Key: 197607706
• Report Number: 1820334-2020-01215
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002020894
• UDI-Public: (01)00827002020894(17)230217(10)10333348
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-401J-FA
• Device Lot Number: 10333348
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR