MAUDE Adverse Event Report: COOK INC CODA BALLOON CATHETER; DQY, CATHETER, PERCUTANEOUS

Model Number	G53025
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - address 1: (b)(6).H3 - device evaluated by mfg?: the device will not be returned to the manufacturer.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.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
It was reported that the coda balloon catheter ruptured during an endovascular abdominal aortic aneurysm repair (evar) procedure for a male patient.Upon opening the device packaging, the balloon protector was present and no damage to the device was identified.Following graft placement into the patient, the coda balloon was to be used for touch-up.Negative pressure was applied to the balloon outside of the patient's body; however, "air continued to be drawn." the user then inserted heparinized saline solution into the device and a pinhole rupture to the balloon material was observed.A new same device was opened to complete the procedure successfully.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
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 or that a death or serious injury occurred; nor is it admission 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
Investigation ¿ evaluation.Cook was notified that a pin hole was identified in a cook coda balloon.The patient was undergoing an endovascular abdominal aortic aneurysm repair (evar) procedure upon opening the device packaging, the balloon protector was present and no damage to the device was identified.Following graft placement into the patient, the coda balloon was to be used for touch-up.Negative pressure was applied to the balloon outside of the patient's body; however, "air continued to be drawn." the user then inserted heparinized saline solution into the device and a pinhole rupture to the balloon material was observed.A new same device was opened to complete the procedure successfully.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A photo was provided by the customer for the investigation.In the photo the user can be seen squeezing the balloon and a jet of fluid can be seen streaming from the balloon.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 dhrs for the reported complaint device lot and the related subassembly lots revealed no recorded non-conformances relevant to the failure mode.A complaint history search identified no other events reported for the related failure mode.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 incorporated does not apply the ifu to this device, which remains under cook's control.The ifu is applied prior to distribution by a cook entity that is a local cook distribution partner in the country of sale.Based on the information provided, no product returned, and the results of the investigation, a definitive root cause for this event could not be established the appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 toa death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: CODA BALLOON CATHETER
• Common Device Name: DQY, CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• 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: 22288097
• Report Number: 1820334-2025-00726
• Device Sequence Number: 21063241
• Product Code: DQY
• UDI-Device Identifier: 00827002530256
• UDI-Public: (01)00827002530256(17)271209(10)16371386
• Combination Product (Y/N): N
• PMA/510(K) Number: K032869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025

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 Model Number: G53025
• Device Catalogue Number: CODA-2-10.0-35-120-40
• Device Lot Number: 16371386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 10/22/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/09/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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
• Patient Sex: Male