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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem 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.
Additional 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
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• MDR Report Key: 6166339
• Report Number: 1820334-2016-01456
• Device Sequence Number: 510010
• Product Code: GBL
• UDI-Device Identifier: 00827002150409
• UDI-Public: (01)00827002150409(17)170301(10)U2469183
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 021304
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention