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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1- customer (person): phone: (b)(6).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
It was reported that a hair-like fiber was found in the sterile package of an upj occlusion balloon catheter.The device did not make patient contact.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
It was reported 24aug2023 that the device could not be returned to cook for evaluation.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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, unchanged, or unavailable.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
In additional information received on 24aug2023, it was reported that a new product was opened to complete the procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary.It was reported that a hair-like fiber was found in the sterile package of an upj occlusion balloon catheter.The device did not make patient contact.A new device was opened to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation evaluation.A document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures of the device were conducted.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 for the complaint device lot was conducted and there was one related nonconformance for foreign matter in which two devices were reworked.A review of complaint history records shows no other complaints associated with the complaint device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied.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.Based on the available information, no product returned, and the results of the investigation, the cause was determined to be due to manufacturing and quality control.The operator tasked with quality control of packaging for this lot has been made aware of this complaint.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: 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: 17607305
• Report Number: 1820334-2023-01144
• Device Sequence Number: 17693762
• Product Code: EYB
• UDI-Device Identifier: 00827002143371
• UDI-Public: (01)00827002143371(17)250302(10)14572207
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/21/2023

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 Expiration Date: 03/02/2025
• Device Model Number: N/A
• Device Catalogue Number: 028006
• Device Lot Number: 14572207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: Not provided; 08/24/2023; 11/21/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 08/24/2023; 09/15/2023; 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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