MAUDE Adverse Event Report: COOK COOK MEDICAL OPEN ENDED URETER CATHETER; CATHETER, URETERAL, GENERAL AND PLASTIC SURGERY

Model Number G14274

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  Injury  

Event Description

Prior to insertion of device into r ureter, no visible issue with catheter.However, one catheter removed from pt, dr (b)(6) noticed the tip was not intact.Per cystoscopy that was actively in use, dr and staff could view remaining piece of tip in r ureter.With sterile graspers, dr was able to retrieve remaining piece of broken catheter.No other pieces visualized on cystoscopy; 70cm accounted for when measured.Pieces sent to operating room supv.No injuries seen at this time.

• Brand Name: COOK MEDICAL OPEN ENDED URETER CATHETER
• Type of Device: CATHETER, URETERAL, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): COOK ; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8865568
• MDR Text Key: 153682075
• Report Number: MW5088794
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2022
• Device Model Number: G14274
• Device Catalogue Number: 020015
• Device Lot Number: 9803796
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR