MAUDE Adverse Event Report: COOK INC URETERAL BALLOON DILATOR; EZN DILATOR, CATHETER, URETERAL

Catalog Number	010014
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that the ureteral balloon could not load onto the wire.It was further noted that yellow material was visible in the inner diameter, blocking the lumen.There was no harm to the patient.

• Brand Name: URETERAL BALLOON DILATOR
• Common Device Name: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7411985
• Report Number: 1820334-2018-01055
• Device Sequence Number: 147444
• Product Code: EZN
• UDI-Device Identifier: 00827002143203
• UDI-Public: (01)00827002143203(17)181110(10)6368675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Catalogue Number: 010014
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1