MAUDE Adverse Event Report: COOK INC AUROUS CENTIMETER VESSEL SIZING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number G11916

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

Event Description

It was reported, a aurous centimeter vessel sizing catheter was used for stent graft placement in a patient of unknown gender or age.A cutdown technique was performed at the access site: the right femoral artery and another manufacturer's 16fr sheath was inserted into the vessel.Two sheaths were inserted in the patient's anatomy; another manufacturer's 16fr sheath and 9fr sheath.The user could advance a wire guide in the 9fr sheath and attempted to advance the complaint aurous centimeter vessel sizing catheter in the 9fr sheath.However, the complaint device could not be advanced in the sheath.After the removal of the 9fr sheath and the complaint device from the patient body, the user found the radiopaque markers was out of position.A total of six bands were out of place.The physician continued to use the 16fr sheath, and a stent graft of another manufacturer was successfully placed.Patient outcome is reportedly good.There were no patient adverse effects.

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: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one aurous centimeter vessel sizing catheter was returned to cook for investigation.The marker bands were noted to be out of place, confirming the reported complaint.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.Through these reviews, cook has confirmed that adequate controls are in place to identify this failure mode prior to distribution.Moreover, an ifu is provided with the device, which states "if resistance is encountered during manipulation, stop and determine the cause before proceeding any further."upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided and the examination of the returned product, investigation has concluded that a cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: AUROUS CENTIMETER VESSEL SIZING CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8556167
• MDR Text Key: 144153061
• Report Number: 1820334-2019-00935
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002119161
• UDI-Public: (01)00827002119161(17)190705(10)7063896
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2019
• Device Model Number: G11916
• Device Catalogue Number: N5.0-35-100-P-10S-PIG-CSC-20
• Device Lot Number: 7063896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9 FR AND 16 FR SHEATHS (GORE).