MAUDE Adverse Event Report: COOK INC UPJ OCCLUSION BALLOON CATHETER; EZL CATHETER, RETENTION TYPE, BALLOON

Model Number	G14337
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: postal code: (b)(6).Pma/510k #: k183323.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a percutaneous nephrolithotomy using a upj occlusion balloon catheter, foreign matter was discovered inside of the adapter.The user connected the inflation adapter to the balloon catheter and tried to inject contrast medium but failed.The user checked the complaint adapter and found a foreign matter inside the adapter.The foreign matter was white and looked like glue.The white foreign matter came out from the adapter and disappeared during the procedure.The user opened same type device and connected the adapter to the same balloon catheter.The new adapter was used without problem and the procedure was completed.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Event summary: as reported, during a percutaneous nephrolithotomy using a upj occlusion balloon catheter, foreign matter was discovered inside of the adapter.The user connected the inflation adapter to the balloon catheter and tried to inject contrast medium but failed.The user checked the complaint adapter and found a foreign matter inside the adapter.The foreign matter was white and looked like glue.The white foreign matter came out from the adapter and disappeared during the procedure.While attempting to adjust the adaptor many times and tightening it strongly, a piece of the adapter broke off.While replacing the adaptor, the user discovered the foreign substance in the proximal end of the balloon catheter.The user opened same type device and connected the adapter to the same balloon catheter.The new adapter was used without problem and the procedure was completed.There have been no adverse effects to the patient reported.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.Only the t-fitting of a upj occlusion balloon catheter was returned for investigation.The t-fitting was broken.The o-ring appeared to be severed and had a flash in the middle that was still attached to the fitting.The o-ring was adhered to the fitting and was unable to be removed from the fitting.The connecting cap appeared to be occluded with an unknown clear substance.When attempting to pass a wire guide through the connecting cap, the connecting cap was closed with the substance.The end cap appeared fine and had no occlusion.A document-based investigation evaluation was performed.No related nonconformances were recorded, and no additional lot-related complaints have been received.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The device is provided with instructions for use which state, "upon removal from the package, inspect the product to ensure no damage has occurred." the returned device was found to have a connecting cap occluded with excess glue, which prevented the injection of contrast fluid.The cause of the event was determined to most likely be a manufacturing quality deficiency.The employee responsible for the production of the device has been retrained.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, 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.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 received 12jan2021: while attempting to adjust the adaptor many times and tightening it strongly, a piece of the adapter broke off.While replacing the adaptor, the user discovered the foreign substance in the proximal end of the balloon catheter.

• Brand Name: UPJ OCCLUSION BALLOON CATHETER
• Common Device Name: EZL CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11132766
• Report Number: 1820334-2021-00034
• Device Sequence Number: 11540987
• Product Code: EZL
• UDI-Device Identifier: 00827002143371
• UDI-Public: (01)00827002143371(17)230402(10)13105022
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021

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: 04/02/2023
• Device Model Number: G14337
• Device Catalogue Number: 028006
• Device Lot Number: 13105022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 12/25/2020
• Supplement Date Received by Manufacturer: 01/12/2021; 02/19/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/20/2021; 03/08/2021
• Patient Sequence Number: 1