MAUDE Adverse Event Report: COOK INC 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	Foreign Body In Patient (2687)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).Event is still under investigation at this time.
Event or Problem Description
When the urologist went to place the catheter during a cystoscopy retrograde procedure, the device snapped in two places.All the pieces were successfully removed with grasping forceps and a new catheter was placed without difficulty.No adverse effects to the patient were reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the dimension verification, complaint history, device history record, document review, visual inspection and specifications 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.The separation showed signs of catheter is being pinched or kinked resulting in 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: FLEXI-TIP URETERAL CATHETER
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6112081
• Report Number: 1820334-2016-01439
• Device Sequence Number: 1168687
• Product Code: GBL
• UDI-Device Identifier: 00827002140165
• UDI-Public: (01)00827002140165(17)170301(10)U2467934
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• 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: 021105
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• 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