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 Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that during inspection, it was observed that there was foreign material inside of the primary package of the aurous centimeter vessel sizing catheter.The catheter did not come into contact with a patient.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), and quality control was conducted during the investigation.The aurous centimeter vessel sizing catheter was not returned for evaluation.However, images were provided that confirmed the unidentified foreign matter within the primary device packaging.A document-based investigation was performed.Review of the device history record shows no nonconforming events.In addition, there were no other reported complaints for this lot number.Based on the information provided, examination of the images provided, and the results of our investigation; the root cause has been attributed to manufacturing.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and 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 ; 8123392235
• MDR Report Key: 7046810
• MDR Text Key: 92789366
• Report Number: 1820334-2017-04014
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002119161
• UDI-Public: (01)00827002119161(17)200130(10)7587631
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• 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?: Yes
• Date Manufacturer Received: 02/08/2018
• Date Device Manufactured: 01/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1