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

Model Number N/A

Device Problem Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 a user has faced a reoccurring issue with the guide wires of femoral artery pressure monitoring sets unraveling, requiring the use of more than one kit per puncture.Another event associated with this event is reported under mdr ref.#1820334-2021-00392.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction- the summary report designation is incorrect; the report is not a summary report.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

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

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.An issue was reported on a wire guide from a femoral artery pressure monitoring set (c-pms-400-fa) from lot 13330274.During a femoral puncture, the wire guide unraveled inside the catheter and had to be removed.This event was captured in mfg.Report reference #: 1820334-2021-00392.The customer also reported recurrent issues in the past, the subject of this complaint.These procedures each required more than one set to be opened per puncture.Cook became aware of this event on 09feb2021 upon being notified by agility logistics.A review of the documentation including the complaint history, manufacturing instructions and quality control of the device was 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 controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) found that the risks of this device are acceptable when weighed against the benefits.A review of the device history record (dhr) could not be conducted due to lack of lot information from the facility.Since potential nonconformances or other complaints from the devices¿ lot could not be confirmed, there is no evidence that nonconforming product exists in house or in the field.The device set is not provided with instructions for use (ifu).Based on the information provided, no returned product and the results of our investigation, it was concluded that the cause of the event was due to a component failure without design or manufacturing deficiency.The wire guide may have been damaged by contact with a sharp edge such as the needle point or calcifications in the patient¿s anatomy, and later unraveled when manipulating it through the catheter.However, without additional information, these possibilities cannot be confirmed with certainty.The appropriate personnel have been notified.Per the quality engineering 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
• MDR Report Key: 11392495
• MDR Text Key: 234250507
• Report Number: 1820334-2021-00861
• Device Sequence Number: 1
• Product Code: DQO
• 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,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-400-FA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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