MAUDE Adverse Event Report: COOK INCORPORATED ULTRAXX; CATHETER, NEPHROSTOMY

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Event Description

Dr.Was trying to use the balloon set but it was leaking.A new product was opened and there were no issues with the second product.Failed product had patient contact but no patient harm.Failed product is available for pickup/return.

• Brand Name: ULTRAXX
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7439437
• MDR Text Key: 105782602
• Report Number: 7439437
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/10/2018

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: Physician
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR