MAUDE Adverse Event Report: COOK INC CONE TIP URETERAL CATHETER; KOD CATHETER, UROLOGICAL

Catalog Number	024605
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/21/2015
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 a cone tip ureteral catheter part tore right down the middle when the staff tried to open it for the ureteroscopy procedure.This issue occurred prior to patient contact.

• Brand Name: CONE TIP URETERAL CATHETER
• Common Device Name: KOD CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8112313
• Report Number: 1820334-2018-03565
• Device Sequence Number: 16519093
• Product Code: KOD
• UDI-Device Identifier: 00827002146631
• UDI-Public: (01)00827002146631(17)180130(10)5611858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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: Health Professional
• Device Expiration Date: 01/30/2018
• Device Catalogue Number: 024605
• Device Lot Number: 5611858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1