MAUDE Adverse Event Report: COOK INC ULTRAXX NEPHROSTOMY BALLOON AND SET; LJE CATHETER, NEPHROSTOMY

Model Number N/A

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported that during a percutaneous nephrolithotomy procedure on a (b)(6) year old female patient, there was a hole in the distal tip of the balloon, causing it to leak.The balloon remained intact.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).A review of the complaint history, functional test, device history record, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use.The ifu for the unb family warns to not overfill the balloon, as it might cause a rupture.The visual inspection of the returned device was functionally checked, and a weakness in the distal tip bond was detected at about 14atm.Once that pressure is reached, water starts to leak out of the distal tip.Upon physical examination it was seen that the distal bond had failed and was the source of the leak.The labeling for the unb balloons lists 20atm as the rated burst pressure.Testing has shown the average burst pressure to be 26.2 atm, with a standard deviation of.79 atm.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

It was reported that during a percutaneous nephrolithotomy procedure on a (b)(6) female patient, there was a hole in the distal tip of the balloon, causing it to leak.The balloon remained intact.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON AND SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5932179
• MDR Text Key: 54045015
• Report Number: 1820334-2016-00904
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002460379
• UDI-Public: (01)00827002460379(17)190509(10)6957364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNBS-6-15-CS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• 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 Age: 28 YR