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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Event is still under investigation at this time.

Event 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.

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
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6112081
• MDR Text Key: 60289434
• Report Number: 1820334-2016-01439
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002140165
• UDI-Public: (01)00827002140165(17)170301(10)U2467934
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• 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: 11/18/2016
• 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: 021105
• 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