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

Model Number	G03831
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was difficult to advance a cook coda lp balloon catheter.The cook coda lp balloon catheter was being advanced over a cook lunderquist wire and through a cook 20 french sheath.During the advancement, the shaft of the balloon catheter "concertina'ed." the device was removed and replaced with another cook coda lp balloon catheter.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.E1: (b)(6).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.
Event or Problem Description
In additional information it was reported that there was no calcification or significant tortuosity present in the vessels used for introduction of the devices.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5; d10 (concomitant products) 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.
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
Blank fields on this form indicate the information is unknown or unavailable.Investigation-evaluation it was reported that it was difficult to advance a cook coda lp balloon catheter.There was no calcification or significant tortuosity present in the vessels used for introduction of the devices used in the procedure.The cook coda lp balloon catheter was being advanced over a cook lunderquist wire and through a cook 20 french sheath.During the advancement, the shaft of the balloon catheter "concertina'ed." the device was removed and replaced with another cook coda lp balloon catheter.There was no calcification or significant tortuosity present in the vessels used for introduction of the devices.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.One coda balloon catheter was returned for investigation.A leak test was performed and there were no leaks identified.There were heavy amounts of biomatter on the device, therefore, the shaft was cleaned to verify if damage is present.Damage is noted on the shaft at approximately 64.5 cm from the winged hub.There appeared to be a bump or raising of the material on the shaft right above the balloon.However, a.035 wire guide was able to be advanced through the entire length of the device without any issues.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 discrepancies relevant to the failure mode.A complaint history search identified no other events reported for the related failure mode.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: balloon introduction and inflation 2.Advance the balloon catheter over a pre-positioned.035-inch wire guide, using a minimum 12 fr introducer sheath for the 9 fr 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.Based on the information provided, inspection of the returned device, and the results of the investigation, the root cause was determined to be component failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr 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 malfunctioned, that a serious injury occurred, or that any cook device caused or contributed to a serious injury.

• Brand Name: CODA LP 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: 23781162
• Report Number: 1820334-2025-01538
• Device Sequence Number: 10170825
• Product Code: DQY
• UDI-Device Identifier: 00827002038318
• UDI-Public: (01)00827002038318(17)270603(10)16086027
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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: G03831
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 16086027
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 02/26/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/15/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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: COOK 20FR INTRODUCER SHEATH; COOK FLEXOR INTRODUCER 20FR (LOT NOT AVAILABLE); COOK LUNDERQUIST 0.035¿ WIRE (LOT NOT AVAILABLE); COOK LUNDERQUIST WIRE
• Patient Sex: Unknown