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

Model Number G01909

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

Customer (person): phone - (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 during a femoral puncture, the guide wire of a femoral artery pressure monitoring set frayed and unraveled inside the catheter during passage.It was necessary to open another kit to complete the procedure.No adverse effects to the patient have been reported.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation an issue was reported with a wire guide from a femoral artery pressure monitoring set (rpn:(b)(4), lot: 13330274).During a femoral puncture, the wire guide unraveled inside the catheter and had to be removed.Cook became aware of this event on (b)(6)2021 upon being notified by agility logistics.The patient reportedly experienced no adverse effects as a result of this incident.A review of complaint history, device history record (dhr), manufacturing instructions (mi), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a photo of the wire guide was provided to cook.The photo depicted the wire guide to be unraveled and the safety wire to be protruding.Unknown biomatter is observed at the distal end, obscuring the distal solder.Cook has concluded that the device was manufactured to specification.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (13330274) and the related wire guide subassembly lot revealed no recorded nonconformances.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.This device is not supplied with an instructions for use (ifu).Based on the information provided, no returned product, and the results of the investigation, a definitive root cause for this event has been traced to component failure unrelated to a deficiency in manufacturing/device design.It is possible that a sharp edge such as the needle tip or tortuous anatomy damaged the wire guide.However, this cannot be confirmed without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 to a death or serious injury if a malfunction occurred.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11385656
• MDR Text Key: 233770673
• Report Number: 1820334-2021-00392
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002019096
• UDI-Public: (01)00827002019096(17)230727(10)13330274
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: G01909
• Device Catalogue Number: C-PMS-400-FA
• Device Lot Number: 13330274
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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