MAUDE Adverse Event Report: COOK UROLOGICAL INC OPEN-END FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

It was reported while doing a cystoscopy for insertion off a stent, the ureteral catheter was inserted through the cystoscope into the ureter, the physician pulled back on the cystoscope to check the position and found the ureteral catheter had snapped inside the patient.The physician was able to remove the snapped off end.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the dimension verification, complaint history, device history record, quality assurance and visual inspection was conducted during the investigation of the returned product.The device was returned for investigation and as per the investigation results, the device did not snap.There was no sign of degradation, the separation showed signs of catheter being cut or pulled to separation.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the provided information and the investigation evaluation the root cause is product use or handling related to user technique.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6166339
• MDR Text Key: 62124967
• Report Number: 1820334-2016-01456
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002150409
• UDI-Public: (01)00827002150409(17)170301(10)U2469183
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 021304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention