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

Model Number G14337

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number- k183323.Event summary: as reported, during a percutaneous nephrolithotripsy, an unknown white substance was found in a upj occlusion balloon catheter.After inserting the balloon catheter into the patient, the physician inflated the balloon and inserted a syringe into the injection port of the inflation/injection adapter for pyelography.However, the physician could not inject urografin contrast medium, as it would not flow through the port of the adapter.Once the device was removed from the patient, the physician removed the screw of the injection port of the adapter and confirmed a white burr-like substance was stuck/clogged in the device.Another product of the same reference number was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, specifications, and quality control procedures and a visual inspection, functional test, and dimensional verification of the device were conducted during the investigation.One upj occlusion balloon was returned for investigation in a used condition.The t-fitting was returned with the device but not attached to the catheter.The catheter length measured 79.6cm.The distal tip was sealed with a smooth finish.No surface damage or manufacturing anomalies were identified on the catheter.A function test was performed by attempting to inflate the balloon with tap water.The balloon would not inflate.The female luer lock fitting was occluded with hard/dried white opaque plastic like material.The debris was removed from the hole in the fitting.Water was again flushed through the t fitting, and a leak was detected from the female luer lock fitting.The debris in the fitting prevented flushing of the catheter.A second function test was performed by injecting water through the inflation valve; again, the balloon did not inflate, and water leaked from the distal end hole in the catheter.Magnification of the distal end of the catheter confirmed the catheter lumens were sealed closed.The most probable cause of the leakage can be attributed to communication between inflation lumen and flushing lumen.A document-based investigation evaluation was also performed.One potentially related nonconformance was recorded; the affected devices were identified and scrapped.No other lot-related complaints have been received.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions, specifications, or quality control procedures.The device is packaged with instructions which caution, ¿using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.Inflation of the balloon 2 or 3 times with an appropriate inflation medium prior to use will allow easier inflation of the balloon.¿ the returned device was found to have an occluded flla injection port, preventing the balloon from being inflated.The occlusion appeared to be plastic debris.Based on the available information, cook has concluded that the cause of the event was most likely a manufacturing quality deficiency.The personnel responsible for production of this device lot 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.

Event Description

As reported, during a percutaneous nephrolithotripsy, an unknown white substance was found in a upj occlusion balloon catheter.After inserting the balloon catheter into the patient, the physician inflated the balloon and inserted a syringe into the injection port of the inflation/injection adapter for pyelography.However, the physician could not inject urografin contrast medium, as it would not flow through the port of the adapter.Once the device was removed from the patient, the physician removed the screw of the injection port of the adapter and confirmed a white burr-like substance was stuck/clogged in the device.Another product of the same reference number was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11177822
• MDR Text Key: 244017842
• Report Number: 1820334-2021-00100
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00827002143371
• UDI-Public: (01)00827002143371(17)230601(10)13219458
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: G14337
• Device Catalogue Number: 028006
• Device Lot Number: 13219458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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