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

Model Number	G03832
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coda lp balloon catheter was difficult to advance during an endovascular abdominal aortic aneurysm repair (evar) procedure on an unknown patient.When the coda balloon was to be used for touch-up during the evar, it became impossible to advance inside the patient's body, in which the device was then removed.Delivery of the catheter was attempted again on the other side; however, resistance was felt a second time.The complaint device was then removed from the patient, and touch-up was performed with a balloon catheter from another manufacturer.The user noted that no damage to the package was found upon opening the device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
H3 - device evaluated by mfg?: device return expected.However, device has not been provided for evaluation at the time of this report.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
Additional information was provided on 10mar2025.Imaging for the event is not available.Procedural notes for the event are not available.None of the devices experienced difficult advancement or removal during the procedure.When asked "was the device difficult to advance through the sheath or through the patient's vessels, the response was "yes." the device was not difficult to remove from the patient.The physician also attempted to use the same device on the other side but confirmed that delivery was difficult.A balloon from another manufacturer was used and delivery was completed on both sides without resistance.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5.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 it was reported that a coda lp balloon catheter was difficult to advance during an endovascular abdominal aortic aneurysm repair (evar) procedure on an unknown patient.When the coda balloon was to be used for touch-up during the evar, it became impossible to advance inside the patient's body, in which the device was then removed.Delivery of the catheter was attempted again on the other side; however, resistance was felt a second time.The complaint device was then removed from the patient, and touch-up was performed with a balloon catheter from another manufacturer.No harm to the patient was reported.Imaging and procedural notes for the event are not available.The cook coda balloon was the only device that experienced difficult advancement or difficult removal in the procedure.When asked "was the device difficult to advance through the sheath or through the patient's vessels, the response was "yes." the user noted that no damage to the package was found upon opening the device.Reviews of documentation including the complaint history, device history record (dhr), drawings, instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.The used complaint device was returned to cook for investigation.There was a slight indentation noted to the distal tip of the catheter.No other damage noted.The od of the coda catheter measured within specification.A sample 0.035" wire guide would not advance through the distal tip of the device.The wire guide was able to be advanced through the proximal end of the shaft but met resistance and would not pass into the tapered portion of the shaft.It was noted that the indentation is not the sight of the resistance.The resistance starts at the point where the taper begins.The tip was cut open, no obstruction/blockage was noted.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 zero nonconformances.A complaint history search identified one other complaint against this product lot submitted by the same customer.No other complaints have been reported.Cook also reviewed product labeling.The device was packaged with ifu t_codalp_rev_4.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.Introducer sheath selection for introduction, it is recommended to use a minimum 14.0 french introducer sheath for the 10.0 french coda balloon catheter and a minimum 12.0 french introducer sheath for the 9.0 french coda lp balloon catheter.Balloon preparation 3.0 to increase ease of insertion, balloon may be lubricated with a thin layer of sterile, biocompatible lubricant.Balloon introduction and inflation 2.Advance the balloon catheter over a pre-positioned.035-inch wire guide, utilizing a minimum 14.0 french introducer sheath for the 10.0 french coda balloon catheter or a minimum 12.0 french introducer sheath for the 9.0 french coda lp balloon catheter.Note: if resistance is met while advancing the wire guide or balloon catheter, determine the cause and proceed with caution.3.Under fluoroscopy, advance the balloon to the desired position using radiopaque markers.Evidence provided by the customer, complaint history, dhr, device failure analysis, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook could not determine 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 LP BALLOON CATHETER
• Common Device Name: 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: 21587255
• Report Number: 1820334-2025-00251
• Device Sequence Number: 8895935
• Product Code: DQY
• UDI-Device Identifier: 00827002038325
• UDI-Public: (01)00827002038325(17)271209(10)16371382
• Combination Product (Y/N): N
• PMA/510(K) Number: K150970
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2025

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: G03832
• Device Catalogue Number: CODA-2-9.0-35-100-32
• Device Lot Number: 16371382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 07/18/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/18/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE EXCLUDER; GORE/DRYSEAL 18FR; MEDICO'S HIRATA/EGOIST (WIRE GUIDE); XLENDER (JAPAN LIFELINE)
• Patient Sex: Unknown