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

Model Number G30365

Device Problems Material Rupture (1546); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, an ultraxx nephrostomy balloon and set ruptured at an unknown pressure.The device was used for access during a percutaneous nephrolithotomy.The balloon was "extremely difficult" to inflate and the knob was hard to turn.After the rupture, the sheath was placed over the balloon and bent in two places (it is unknown which device bent).A new device was used to complete the procedure successfully.No unintended section of the device remained inside the patient.The patient did not require any additional procedures due to the occurrence.The patient did not experience any adverse effects.

Manufacturer Narrative

Event summary: as reported, an ultraxx nephrostomy balloon and set ruptured at an unknown pressure.The device was used for access during a percutaneous nephrolithotomy.The balloon was "extremely difficult" to inflate and the knob was hard to turn.After the rupture, the sheath was placed over the balloon and bent in two places (it is unknown which device bent).A new device was used to complete the procedure successfully.No unintended section of the device remained inside the patient.The patient did not require any additional procedures due to the occurrence.The patient did not experience any adverse effects.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, specifications, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded.One additional complaint was reported for this lot number for an unrelated failure mode.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.A review of relevant manufacturing documents was conducted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿make all aspiration and injection maneuvers with the lock lever pushed left, i.E., unlocked.In this position, you can freely pull the piston back for aspiration, or push it forward for injection.To lock the piston in position, slide the lever right to the straight up position¿10.To inflate the balloon, engage the lock lever, turn the palm grip on the piston clockwise slowly until the desired inflation pressure is reached.Close the stopcock, (lock lever) on the inflation device to maintain pressure.¿ based on the available information, cook has concluded that a cause for this event could not be established.Cook will continue monitoring of similar complaints and has 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 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 AND SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• 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: 13971384
• MDR Text Key: 291963201
• Report Number: 1820334-2022-00512
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002303652
• UDI-Public: (01)00827002303652(17)241019(10)14289788
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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 Model Number: G30365
• Device Catalogue Number: UNBS-10-15
• Device Lot Number: 14289788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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