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	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Cook was notified that the balloon of a cook coda balloon catheter ruptured during a thoracic aortic procedure.The target site was the right thoracic aorta (zone 3).First, a competitor's stent graft was placed.Next the cook coda balloon catheter was positioned.There was no resistance in advancement, and no calcification was observed.After positioning the cook coda balloon catheter, the initial inflation of the balloon was completed using a 50cc syringe with 1:3 diluted contrast agent.During the first inflation in the proximal portion of the competitor's graft, no excessive pressure was applied, and the operator did not experience any sensation of rupture.However, during the second inflation in the proximal portion of the competitor's graft, the coda balloon failed to inflate, indicating a rupture of the device.To complete the procedure, a cook coda balloon catheter from a different lot number was used for inflation.It was reported that the user is a thoracic graft instructor and has extensive experience using thoracic stent grafts and the cook coda balloon catheter and it is unlikely there was a problem with the doctor's usage method.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluation anticipated, but not yet begun.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
Additional information: d9 - date returned to mfg.Investigation ¿ evaluation: cook was notified that the balloon of a cook coda balloon catheter ruptured during a thoracic aortic procedure.The target site was the right thoracic aorta (zone 3).First, a competitor's stent graft was placed.Next the cook coda balloon catheter was positioned.There was no resistance in advancement, and no calcification was observed.After positioning the cook coda balloon catheter, the initial inflation of the balloon was completed using a 50cc syringe with 1:3 diluted contrast agent.During the first inflation in the proximal portion of the competitor's graft, no excessive pressure was applied, and the operator did not experience any sensation of rupture.However, during the second inflation in the proximal portion of the competitor's graft, the coda balloon failed to inflate, indicating a rupture of the device.To complete the procedure, a cook coda balloon catheter from a different lot number was used for inflation.It was reported that the user is a thoracic graft instructor and has extensive experience using thoracic stent grafts and the cook coda balloon catheter and it is unlikely there was a problem with the doctor's usage method.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), drawings, and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.Cook received one used coda balloon catheter.A leak was confirmed and appears to be coming from damage to the middle of the balloon.However, there is evidence to suggest that the device was manufactured to specification.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 did not reveal any related quality control discrepancies.A complaint history search identified no other events reported for the related failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook did not review product labeling.The manufacturer does not apply an ifu for this product.Instructions for use are applied by the local distribution partner.Based on the information provided, inspection of the returned device, and the results of the investigation, cook could not establish a definitive cause for the reported failure.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 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: 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: 23532355
• Report Number: 1820334-2025-01388
• Device Sequence Number: 13308577
• Product Code: DQY
• UDI-Device Identifier: 00827002530256
• UDI-Public: (01)00827002530256(17)280512(10)16594886
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 16594886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO RELAY PRO 30 X 250.
• Patient Sex: Unknown