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

Model Number G01909

Device Problems Material Frayed (1262); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 the wire guide of a femoral artery pressure monitoring set frayed.As the user was attempting to insert the device into the patient, the wire guide would not advance, which was attributed to angulation.As the wire guide was removed, it became "tangled in the tip of the needle", causing it to fray.A different model device was chosen to complete the procedure with no adverse effects to the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.

Event Description

Additional information was provided on 26aug2021.It was reported that the patient required the device to monitor femoral blood pressure.A femoral puncture was selected as "it was not possible to monitor blood pressure through arterial puncture due to the degree of obesity of the patient".The patient was bedridden.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.Agility logistics (brazil) contacted cook on 06jul2021 stating that, when the user tried to pass the catheter from a c-pms-400-fa tray set from lot# 13342214, the wire guide did not progress properly.When an attempt to remove the wire guide was made, it became frayed when it contacted the distal tip of the needle.There were no adverse effects for the patient.Reviews of the documentation, including the complaint history, device history record, manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be performed.However, 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 device history record (dhr) for lot 13342214, as well as component lots ic13250506, ic13263478 and ic13250009, found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no additional complaints associated with the final product lot number.Information provided by the review of the dmr, dhr and lack of product return, cook was unable to determine if the product was manufactured within specification.There is no evidence that nonconforming material exists in house or in the field.Cook was unable to conduct a labeling review, as this product is not supplied with an instructions for use pamphlet.Based on the information provided, no returned product and the results of our investigation, it was concluded that the likely cause for the failure was an unintended user error, as it is generally recommended to remove the needle before withdrawing the wire to avoid damage.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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.

• 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
• 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: 12168148
• MDR Text Key: 261768152
• Report Number: 1820334-2021-01809
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002019096
• UDI-Public: (01)00827002019096(17)230802(10)13342214
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2023
• Device Model Number: G01909
• Device Catalogue Number: C-PMS-400-FA
• Device Lot Number: 13342214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2020
• 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