MAUDE Adverse Event Report: COOK INC URETERAL BALLOON DILATOR; EZN DILATOR, CATHETER, URETERAL

Model Number	G14261
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation-evaluation: a review of the complaint history, device history record, instructions for use, manufacturing records, quality control, and specifications of the device was conducted during the investigation.The device was not returned for visual inspection, it had been discarded by the customer at the conclusion of the case, therefore physical evaluation could not performed.A review of the device history record did not reveal any nonconformances associated with lot number 9130571.A review of complaint history records did not reveal any additional complaints associated with lot 9130571.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Per the quality engineering risk assessment , no further action is necessary as there is no evidence to suggest there is nonconforming product in house or in the field.Based on the information provided, no returned product, and the results of the investigation, a definitive cause could not be established.Cook will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It is reported during a ureteral dilation procedure to treat stenosis using a cook ureteral balloon dilator, the balloon burst while it was being inflated.It was inflated with 10cc of pressure.This device could not be used to complete the procedure.The physician then used a laser to complete the procedure.The product issue and additional method needed to finish the procedure resulted in an additional 30 minutes of procedure/general anesthesia time for the patient.No adverse events have been reported as a result of the alleged malfunction.Additional information was requested about the patient and event.The customer declined to provide any additional details.

• Brand Name: URETERAL BALLOON DILATOR
• Common Device Name: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8475123
• Report Number: 1820334-2019-00672
• Device Sequence Number: 11131239
• Product Code: EZN
• UDI-Device Identifier: 00827002142619
• UDI-Public: (01)00827002142619(17)210830(10)9130571
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K813278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: G14261
• Device Catalogue Number: 010004
• Device Lot Number: 9130571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1