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

Catalog Number	AUBS-4-4
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 was reported an ascend® aq® ureteral balloon catheter popped during use.Additional information has been requested with regards to the event and patient; however, nothing has been made available to date.As reported, there were no adverse consequences to the patient as a result of this reported issue.
Additional Manufacturer Narrative
(b)(4).Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, quality control data, and specifications.One device was returned for investigation.A stock inflation device was used to perform a functional test.The balloon was inflated to approximately 4 atm.The balloon maintained the pressure.A visual examination noted no leaks or damage.The customer stated the balloon popped, however, the device returned had the balloon intact and a functional test determined there were no leaks.A review of the device history record was performed and noted there were no non-conformances associated with the reported failure mode.A search of complaint records revealed this is the only complaint associated with lot 7505117.The following warnings are found in the instructions for use (ifu) that accompany this device.Warnings-always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide, or any other gas.Do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information a definitive cause for the reported failure mode ¿balloon popped¿ cannot be established.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
There has been no new event information received since the last report was submitted on 06-aug-2018.
Additional Manufacturer Narrative
(b)(4).Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, quality control data, and specifications.One device was returned for investigation.A stock inflation device was used to perform a functional test.The balloon was inflated to approximately 4 atm.The balloon maintained the pressure.A visual examination noted no leaks or damage.The customer stated the balloon popped, however, the device returned had the balloon intact and a functional test determined there were no leaks.A review of the device history record was performed and noted there were no non-conformances associated with the reported failure mode.A search of complaint records revealed this is the only complaint associated with lot 7505117.The following warnings are found in the instructions for use (ifu) that accompany this device.Warnings-always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide, or any other gas.Do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information a definitive cause for the reported failure mode ¿balloon popped¿ cannot be established.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
There has been no new event information received since the last report was submitted on 06-aug-2018.
Event or Problem Description
Additional information provided by the user facility.The balloon popped during a cystoscope and laser lithotripsy procedure during ureteral balloon dilation.The surgeon states he followed the manufacturers guidelines and instructions for use included with the product.The balloon was inflated with cystgraffin using a 20-ml syringe.The balloon burst longitudinally.The procedure was completed using another ureteral balloon catheter.There was no unintended section of the device remaining inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: ASCEND® AQ® URETERAL BALLOON CATHETER
• Common Device Name: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7378211
• Report Number: 1820334-2018-00815
• Device Sequence Number: 16571754
• Product Code: EZN
• UDI-Device Identifier: 00827002328341
• UDI-Public: (01)00827002328341(17)191209(10)7505117
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K040127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2018

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: 12/09/2019
• Device Catalogue Number: AUBS-4-4
• Device Lot Number: 7505117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 08/14/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 08/06/2018; 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1