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

Model Number	G03832
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon of a cook coda lp balloon catheter ruptured while being used.There were no issues during the preparation of the balloon.The balloon was being used in severely tortuous abdominal vessels that contained non-circumferential calcification.The balloon was inflated to the appropriate volume but burst during the first inflation.A new balloon from another manufacturer was used for touching up without any problems.The patient recovered.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 not returned to 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 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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.Correction: d4 - lot #.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
Additional information was received 21aug2025.The ballooning was performed at the proximal portion of the graft.There was some calcification present.An unknown sheath was used to introduce the balloon.The balloon was inflated in accordance with the ifu instructions, at which volume the balloon ruptured.The device was inflated inside the graft when the balloon burst.No planning and sizing, imaging, or additional patient information can be provided.
Additional Manufacturer Narrative
Correction: d10.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
Investigation ¿ evaluation: it was reported that the balloon of a cook coda lp balloon catheter ruptured while being used.There were no issues during the preparation of the balloon.The balloon was being used in severely tortuous abdominal vessels that contained non-circumferential calcification.The balloon was inflated to the appropriate volume but burst during the first inflation.A new balloon from another manufacturer was used for touching up without any problems.The patient recovered.Additional information was received on 21aug2025.The ballooning was performed at the proximal portion of the graft.There was some calcification present.An unknown sheath was used to introduce the balloon.The balloon was inflated in accordance with the ifu instructions, at which volume the balloon ruptured.The device was inflated inside the graft when the balloon burst.No planning and sizing, imaging, or additional patient information can be provided.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation including the complaint history, device history record, quality control procedures, drawing and instructions for use (ifu) of the device, were completed during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination of the device could not be completed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that appropriate inspections are in place relative to the reported device failure.A review of the device history record (dhr) found no quality control discrepancies.It should be noted that there were no other complaints associated with the final product lot number.Cook was unable to review product labeling.The manufacturer does not apply an ifu for this product.Instructions for use are applied by the local distribution partner.Evidence provided by the complaint facility, complaint history, dhr, and manufacturing documents 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, no returned device, and the results of this investigation, a definitive cause for the failure could not be established.The patient had some calcification present in the area where the balloon was inflated.It is possible the patient¿s anatomy contributed to this incident.However, this cannot be confirmed without additional information.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 patient and/or event details has been received since the previous medwatch report was sent.

• 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: 22786255
• Report Number: 1820334-2025-00975
• Device Sequence Number: 13228943
• Product Code: DQY
• UDI-Device Identifier: 00827002038325
• UDI-Public: (01)00827002038325(17)280430(10)16580218
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/13/2026

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: G03832
• Device Catalogue Number: CODA-2-9.0-35-100-32
• Device Lot Number: 16580218
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 01/22/2026; 03/05/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 08/25/2025; 01/22/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEKILA BALLOON.; HEKILA BALLOON.; MEDICO'S HIRATA AORFIX (RPN UNKNOWN, LOT UNKNOWN).
• Patient Sex: Female