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

Catalog Number	AUBS-4-4
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility medwatch report # (b)(4).(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.(b)(4).
Event or Problem Description
It was reported during an unknown procedure the ascend aq ureteral balloon catheter was used.As reported a ureteral balloon dilator was placed over the guidewire.The balloon was inflated and it spontaneously ruptured.The balloon was removed and examined.No fragments were left inside the patient.No injury noted.
Additional Manufacturer Narrative
Method codes: device not returned (4114).Conclusion codes: cause not established (4315).Investigation/evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, and quality control data.A review of the device history record revealed there are no non-conformances related to the reported failure.A review of complaint history records shows this complaint to be the only one associated with complaint lot number: 7452943.Per the instructions for use (ifu): balloon catheter introduction and inflation: 1.Under fluoroscopic control, cystoscopically pass a wire guide (up to.038-inch diameter) the desired distance into the ureter beyond the area of planned dilation.2.Activate the aq hydrophilic coating by immersing the balloon and catheter in a sterile physiological solution for approximately 30 seconds.3.Carefully advance the balloon catheter over the previously placed wire guide under fluoroscopic guidance utilizing the radiopaque markers to ensure proper positioning.Advance catheter so the entire balloon extends beyond the end of the cystoscope before inflating the balloon.4.Prepare inflation device in standard manner and purge all air from syringe and tubing.To ensure proper regulation of balloon pressure, use of a balloon inflation device and pressure gauge is recommended.5.Attach the prepared inflation device to the balloon lumen, open the stopcock on the inflation device and inflate the balloon.6.Close the stopcock on the inflation device for at least 30 seconds to maintain pressure and allow adequate dilation.Time, rather than excessive pressure, is the key factor in transluminal dilation.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.The investigation results are inconclusive.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There has been no additional event information received since the last report was submitted on 13jul2018.

• 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: 7684969
• Report Number: 1820334-2018-02058
• Device Sequence Number: 13624215
• Product Code: EZN
• UDI-Device Identifier: 00827002328341
• UDI-Public: (01)00827002328341(17)191117(10)7452943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: 11/17/2019
• Device Catalogue Number: AUBS-4-4
• Device Lot Number: 7452943
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR