MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, PERCUTANEOUS

Catalog Number C-UTLMY-501J-PED-IHI-CCT

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/19/2019

Event Type  malfunction  

Event Description

Patient presented with septic shock.Requiring continuous infusions and close monitoring of progression of acute respiratory failure.Patient was in need of central access which was done by doctoral fellow being proctored by attending physician.The fellow left a guidewire in the patient inadvertently.Guidewire was identified via x-ray.Family notified and patient was taken to ir shortly after to remove the retained cvl wire in ivc and place a new cvl.

• Brand Name: COOK
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9626890
• MDR Text Key: 176252825
• Report Number: 9626890
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-UTLMY-501J-PED-IHI-CCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4380 DA