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

Catalog Number	AUBS-5-6
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a patient underwent a ct scan of the urinary tract due to pyelonephritis that was acquired at another hospital.During the ct, a foreign body was noted.The cap-shaped foreign body was removed with a rigid ureteroscope.The physician reviewed the patient's medical records and determined approximately 10 years ago, at another hospital, the patient was treated by using a ureteral stent (manufactured by another company) and a cook 'ascend® aq® ureteral balloon catheter'.It is unknown exactly what device the foreign body came from but is suspected to potentially be from the 'ascend® aq® ureteral balloon catheter'.
Additional Manufacturer Narrative
E3: customer occupation = unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Correction: h6 (annex f) investigation ¿ evaluation as reported, a patient underwent a ct scan of the urinary tract due to pyelonephritis that was acquired at another hospital.During the ct, a foreign body was noted.The cap-shaped foreign body was removed with a rigid ureteroscope.The physician reviewed the patient's medical records and determined approximately 10 years ago, at another hospital, the patient was treated by using a ureteral stent (manufactured by another company) and a cook 'ascend® aq® ureteral balloon catheter'.No other adverse effects have been reported.It is unknown exactly what device the foreign body came from but is suspected to potentially be from the 'ascend® aq® ureteral balloon catheter'.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed however, a photo was supplied of the removed foreign body; the foreign body appears to be the protective sleeve of the device which is part of the packaging and is instructed to be removed and discarded prior to device placement.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformance's relevant to the failure mode.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The instructions for use (ifu) that is packaged with the device was reviewed for relevant information pertaining to the reported failure mode.Relevant information within ifu t_aub_rev1 includes: ¿instructions for using ascend aq ureteral dilation balloon catheter balloon preparation: 1.Upon removal from the package inspect the balloon catheter to ensure no damage has occurred during shipment.2.Remove the protective sleeve from the balloon and discard¿.¿ ¿balloon catheter introduction and inflation¿ ¿balloon deflation and withdrawal¿ ¿how supplied: upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of the investigation, it appears that failure to follow the ifu instructions of removing the protective sleeve, and thus user error, was the likely cause of the complaint.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.As the device was not meant to be indwelling and the future risk to the patient is negligible, a review of the risk assessment was not required/completed.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ASCEND® AQ® URETERAL BALLOON CATHETER
• Common Device Name: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17461167
• Report Number: 1820334-2023-01027
• Device Sequence Number: 16780590
• Product Code: EZN
• UDI-Device Identifier: 00827002328389
• UDI-Public: (01)00827002328389(17)150101(10)U2159884
• Combination Product (Y/N): N
• PMA/510(K) Number: K040127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2015
• Device Catalogue Number: AUBS-5-6
• Device Lot Number: U2159884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown