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

Model Number	G02058
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter included in the femoral artery pressure monitoring set fractured at the hub.Upon arrival in the icu post-surgery, it was noted that the femoral arterial line had been sheared off.The surgeon was promptly notified, and the patient was transferred to the cardiovascular interventional laboratory (cvil) for remangiography.On (b)(6) 2025, the patient was received in cvil following an off-pump coronary artery bypass grafting (opcabcg) procedure involving three grafts.The femoral cannula was in situ in the left femoral artery and sutured to the skin.The right groin was bruised and showed signs of hematoma from a coronary angiogram performed on (b)(6)2025.The patient was intubated and ventilated.An ultrasound of the left groin revealed a foreign body, which was visible on the ultrasound-guided access.A 4fr sheath was initially inserted into the right femoral artery (rfa), which was later upgraded to a 6fr 45cm sheath.The foreign body was successfully retrieved using a snare.Post-angiography revealed trauma to the vessel, but there was no bleeding from the right groin.A competitor device (5fr) was used to close the right groin.The patient was then transferred back to the icu.Following the removal of the line in cvil, the patient's icu stay proceeded as expected.Subsequently, the patient was transferred to the cardiology ward (ward 41) and was discharged on (b)(6) 2025.No other adverse effects were reported for this incident.Additional information regarding event details has been requested but is currently unavailable.Kl 4/18/2025.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4 - pma/510(k) #: preamendment e1 - (b)(6) 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.Kl 4/182025.
Additional Manufacturer Narrative
H3: device evaluated by mfg? device not returned to manufacturer.Investigation ¿ evaluation: it was reported that the catheter included in the femoral artery pressure monitoring set fractured at the hub.Upon arrival in the intensive care unit (icu) post-surgery, it was noted that the femoral arterial line had been sheared off.The surgeon was promptly notified, and the patient was transferred to the cardiovascular interventional laboratory (cvil) for remangiography.On (b)(6), at 20:18, the patient was received in cvil following an off-pump coronary artery bypass grafting (opcabcg) procedure involving three grafts.The femoral cannula was in situ in the left femoral artery and sutured to the skin.The right groin was bruised and showed signs of hematoma from a coronary angiogram performed on (b)(6) 2025.The patient was intubated and ventilated.An ultrasound of the left groin revealed a foreign body, which was visible on the ultrasound-guided access.A 4fr sheath was initially inserted into the right femoral artery (rfa), which was later upgraded to a 6fr 45 cm sheath.The foreign body was successfully retrieved using a snare.Post-angiography revealed trauma to the vessel, but there was no bleeding from the right groin.A competitor device (5fr) was used to close the right groin.The patient was then transferred back to the icu.Following the removal of the line in cvil, the patient's icu stay proceeded as expected.Subsequently, the patient was transferred to the cardiology ward (ward 41) and was discharged on (b)(6) 2025.No other adverse effects were reported for this incident.Additional information regarding event details has been requested but is currently unavailable.Reviews of the complaint history, device history record (dhr), drawing, manufacturing instructions (mi), quality control procedures, and specifications of the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots did not reveal any related non-conformances.A complaint history search did not identify any other events for a related failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming products exist either in house or in the field.The product is not supplied with instructions for use (ifu) pamphlet.Based on the information provided, no returned device, and the results of the investigation, a definitive root cause for this event could not be established.It is possible that the catheter was inadvertently pulled by patient movement.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 toa death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Common Device Name: 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: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 21866136
• Report Number: 1820334-2025-00413
• Device Sequence Number: 17323789
• Product Code: DQO
• UDI-Device Identifier: 00827002020580
• UDI-Public: (01)00827002020580(17)271203(10)16364675
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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
• Operator of Device: Health Professional
• Device Model Number: G02058
• Device Catalogue Number: C-PMS-401-FA
• Device Lot Number: 16364675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown