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

Catalog Number	AUB-4-4
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook medical ultraxx nephrostomy balloon and set (unbs-10-15-cs), cystoscope, inflation device, and guide wire.(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, during a ureteral dilatation procedure, the doctor placed the balloon of the ascend® aq® ureteral balloon catheter over the guide wire, connected the inflation device, and found that the balloon did not inflate under fluoroscopy.The doctor removed balloon and saw that the balloon has been compromised as it was unable to inflate at all.The balloon was not placed through any equipment, only over the guide wire.Additional information was received 21aug2018: the issue with the device was noticed while inflating the balloon.The balloon burst longitudinally and another product was used to complete the procedure.There was no harm to the patient.
Event or Problem Description
There has been no new information received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Conclusions code: cause not established (4315).Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, instructions for use, quality control data, and specifications.One device was returned.The returned balloon was returned with dried contrast.A visual examination noted the balloon is split longways 3.3 cm in length.The device history record was reviewed.There were no non-conformances associated with the complaint device lot number (ns6963768).A search of complaint records revealed this is the only complaint associated with complaint lot number (ns6963768).The device manufacturing record was reviewed and no notable gaps in production or processing controls were noted.The intructions for use (ifu) provides the following warnings and precautions: 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.Precautions: do not exceed the maximum rated burst pressure (listed on label) for this balloon device.How supplied: store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred.The returned ascend aq ureteral balloon catheter was found to have a longitudinal split in the balloon material.Dried contrast media was also present on the balloon material.The definitive cause of the split in the balloon material is not known; however, it is possible the device was cut during the procedure.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 warranted.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.

• 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: 7859700
• Report Number: 1820334-2018-02613
• Device Sequence Number: 13771076
• Product Code: EZN
• UDI-Device Identifier: 00827002328259
• UDI-Public: (01)00827002328259(17)190511(10)NS6963768
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K040127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 05/11/2019
• Device Catalogue Number: AUB-4-4
• Device Lot Number: NS6963768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1