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

Catalog Number C-PMS-400-FA

Device Problem Unraveled Material (1664)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 of a femoral artery pressure monitoring set "was not suitable for the procedure".The device was intended to be used for a right femoral artery puncture, but ultimately made no patient contact as the wire was noted to be damaged upon opening the device.A new device was used to complete the procedure.Photos of the device provided by the user facility show the wire to be elongated.Additional information regarding the device has been requested but is unavailable at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged 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

In additional information received on 27feb2020, it was reported that the damage to the wire was noticed after it was removed from the holder.There was no difficulty experienced when removing the wire guide from the holder.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H6 method code: (4114) device not returned.Investigation evaluation.(b)(6) from (b)(6) informed cook on 06feb2020 of an incident involving a femoral artery pressure monitoring set [rpn: c-pms-400-fa] from lot number 9782928.On (b)(6) 2020 during a right femoral artery puncture procedure, the wire guide was removed from the wire guide holder without difficulty but was found to be elongated.The wire guide did not make patient contact, a new device was used to complete the procedure, and there were no adverse effects to the patient due to this incident.A review of the complaint history, device history record (dhr), manufacturing instructions (mi) and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos of the device were provided by the user facility showing an elongated portion of the wire towards the distal end.Based on the information provided, cook has concluded that the product 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 found that this product is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot (9782928) and the related wire guide sub-assembly lot revealed one recorded non-conformance for "solder, broken" in which two devices were scrapped.A database search found no other events associated with the reported device lot.As there are adequate inspection activities established and objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, no product returned, and the results of the investigation, a root cause was traced to a component failure without a manufacturing or design deficiency.It is possible the customer tried to put their own curve on the wire guide, which can cause damage to the wire guide.It is also possible the solder of the safety wire broke.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.

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: 9716423
• MDR Text Key: 201054348
• Report Number: 1820334-2020-00362
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002019096
• UDI-Public: (01)00827002019096(17)220603(10)9782928
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/03/2022
• Device Catalogue Number: C-PMS-400-FA
• Device Lot Number: 9782928
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR