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

Model Number	G46033
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: purchasing.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or after the device investigation is complete.
Event or Problem Description
It was reported, during a mini percutaneous nephrolithotomy (pcnl) using a ultraxx nephrostomy balloon, the balloon was broken.Water was used to inflate the balloon to around 20atm, but the balloon broke after 20 seconds.Another new device was used to finished the procedure.No adverse effects have been reported due to the alleged malfunction.On 08oct2020, the manufacturer investigation of the returned device noted a tear in the balloon that would suggest the balloon ruptured during use.
Additional Manufacturer Narrative
Event summary it was reported, during a mini percutaneous nephrolithotomy (pcnl) using a ultraxx nephrostomy balloon, the balloon was broken.Water was used to inflate the balloon to around 20atm, but the balloon broke after 20 seconds.Another new device was used to finish the procedure.No adverse effects have been reported due to the alleged malfunction.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 and functional test of the device were conducted during the investigation.One open package containing an ultraxx nephrostomy balloon was returned for investigation.The balloon catheter and teflon sheath were in a used condition.Under magnification, a tear was visible in the balloon material.A document-based investigation evaluation was performed.One related nonconformance was recorded; the affected devices were scrapped and not replaced.One additional complaint was received from this product lot from the same user facility.All devices are leak tested during quality inspection.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 caution, ¿do not exceed the maximum rated burst pressure (listed on label) for this balloon device.¿ and, ¿do not pre-inflate the balloon.¿ the ifu also has instructions for proper balloon catheter introduction and proper use of the inflation device.Devices undergo quality inspections to visually examine each balloon for defects and leaks prior to distribution.Based on the available information, cook has concluded that a cause for the damage could not be determined.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.

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10754343
• Report Number: 1820334-2020-01962
• Device Sequence Number: 11047408
• Product Code: LJE
• UDI-Device Identifier: 00827002460331
• UDI-Public: (01)00827002460331(17)220904(10)9990280X
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K024050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: 09/04/2022
• Device Model Number: G46033
• Device Catalogue Number: UNB-6-15
• Device Lot Number: 9990280X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MINI NEPHROSCOPE; MINI NEPHROSCOPE