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

Catalog Number 028006

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) number: 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 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 Description

It was reported that a patient was undergoing a second percutaneous nephrolithotomy (pnl) procedure for left renal stones.During the procedure, the user inserted an upj occlusion balloon catheter transurethrally using a cystoscope.The user then found the residue of the stones from the previous pnl procedure in the l2 level of the urinary duct when a retrograde pyelography was performed.The user attempted to inflate the device balloon around the l3 level by injecting 0.4cc of contrast media but strong resistance was met and the balloon would not inflate as it was noted to be in the narrow part of the urinary duct.The user then injected 0.5cc of contrast media and the balloon suddenly inflated.The user then confirmed fluoroscopically that the contrast media was leaking outside the urinary duct.The user determined the urinary duct was damaged, placed a double j stent in the duct, and ended the procedure.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Event Description

Additional information received 11jul2022: imaging of the procedure will not be provided for investigation.The stent was placed due to the urinary duct damage.The damage to the urinary duct was not confirmed by scope.The patient did not experience any adverse effects due to this occurrence and it was reported that no clinical symptoms (such as back pain, fever, inflammatory symptoms, or elevated creatinine levels) occurred.The patient did not have any other pre-existing conditions and the patients urinary duct was not abnormally or unusually narrow, the urinary duct narrowed within the physiological range.

Manufacturer Narrative

B5: additional information received 11jul2022.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, 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.

Manufacturer Narrative

Event description: it was reported that a patient was undergoing a second percutaneous nephrolithotomy (pnl) procedure for left renal stones.During the procedure, the user inserted an upj occlusion balloon catheter transurethrally using a cystoscope.The user then found the residue of the stones from the previous pnl procedure in the l2 level of the urinary duct when a retrograde pyelography was performed.The user attempted to inflate the device balloon around the l3 level by injecting 0.4cc of contrast media but strong resistance was met and the balloon would not inflate as it was noted to be in the narrow part of the urinary duct.The user then injected 0.5cc of contrast media and the balloon suddenly inflated.The user then confirmed fluoroscopically that the contrast media was leaking outside the urinary duct.The user determined the urinary duct was damaged, placed a double j stent in the duct, and ended the procedure.Additional information received 11jul2022: imaging of the procedure will not be provided for investigation.The stent was placed due to the urinary duct damage.The damage to the urinary duct was not confirmed by scope.The patient did not experience any adverse effects due to this occurrence and it was reported that no clinical symptoms (such as back pain, fever, inflammatory symptoms, or elevated creatinine levels) occurred.The patient did not have any other pre-existing conditions and the patients urinary duct was not abnormally or unusually narrow, the urinary duct narrowed within the physiological range.Investigation - evaluation reviews of specifications, instructions for use (ifu), quality control procedures, and interview of personnel were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The relevant manufacturing documents were reviewed.It was concluded that due to the procedure of leak testing 100% of produced lots of this catalog number, sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: ¿potential adverse events; tissue trauma; perforation; infection; hematuria due to local ureteral bleeding instructions for use - press the syringe tip into the inflation check valve.Note: if the syringe is not inserted far enough, the balloon will not inflate or deflate when needed.The syringe will fit securely in the inflation check valve.¿ inflate the balloon, ensuring not to inflate above 1.0 ml.Inflating and deflating the balloon for one cycle prior to patient contact will verify the functionality of the balloon.¿ the narrative from the customer indicates that the balloon eventually leaked and alludes to the balloon inflation causing damage to the patient¿s urinary duct.It was not able to be ruled out that the cause of the rupture was due to the added external pressure from the patient's narrow urinary duct.The cause could not be determined given the available information.Per the quality engineering risk assessment, no further action is required.We 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 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
• Type of Device: EZL CATHETER, RETENTION TYPE, BALLOON
• 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: 14958286
• MDR Text Key: 295507658
• Report Number: 1820334-2022-01173
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 028006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other