MAUDE Adverse Event Report: COOK INC UPJ OCCLUSION BALLOON CATHETER; EYB CATHETER, URETERAL, GASTRO-UROLOGY

Model Number	G14337
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the upj occlusion balloon catheter's package was found unsealed prior to an unspecified procedure.The procedure was completed by using another same-like device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
G4- pma/510(k) #: k183323.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.
Additional Manufacturer Narrative
Correction: d4: model # = gpn #.Investigation - evaluation.It was reported the upj occlusion balloon catheter's package was found unsealed prior to an unspecified procedure.The procedure was completed by using another same-like device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.The complaint device was not returned; therefore, no functional testing or visual inspections could be performed; however, a photo was provided that shows a partially opened seal.Cook has concluded 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 device history record (dhr) found no related non-conformances reported for lot.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: how supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.It is not possible to rule out shipping/handling as contributing to the complaint.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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: UPJ OCCLUSION BALLOON CATHETER
• Common Device Name: EYB CATHETER, URETERAL, GASTRO-UROLOGY
• 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: 19661107
• Report Number: 1820334-2024-00897
• Device Sequence Number: 6483569
• Product Code: EYB
• UDI-Device Identifier: 00827002143371
• UDI-Public: (01)00827002143371(17)261120(10)NS15764319
• Combination Product (Y/N): N
• 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): 09/13/2024

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: G14337
• Device Catalogue Number: 028006
• Device Lot Number: NS15764319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• 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: Unknown