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

Catalog Number N5.0-35-100-P-10S-PIG-CSC-20

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported by the user facility, "the physician stated that they could not see the tip under fluro, product is no good." there were no known adverse patient consequences reported as a result of this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Investigation - evaluation a review of manufacturing instructions, trends, complaint history, device history record, specifications, quality control data, and visual inspection / functional testing of four unopened devices from the same lot as the device alleged in this report was conducted during the investigation.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The used device was not returned.Four sealed (unused) aurous centimeter vessel sizing catheter (n5.0-35-100-p-10s-pig-csc-20) were returned from lot 6922581(same lot as used device).Twenty-one marker bands were present on each of the devices.A portion of catheter discoloration is noted on device 1.Portion of catheter under label is not discolored.All four catheters were tested for visualization of tip using fluoroscopy.Three separate test were performed on all four devices.First test was a direct image of the device.The second test used a plexiglass model with each of the devices, this mimics in patient use.The third test used aluminum slab model, which also mimics in patient use.All four devices passed all three tests.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6730561
• MDR Text Key: 80623744
• Report Number: 1820334-2017-01821
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002119161
• UDI-Public: (01)00827002119161(17)190505(10)6922581
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: N5.0-35-100-P-10S-PIG-CSC-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 10/24/2017
• Date Device Manufactured: 05/05/2016
• 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