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

Catalog Number UNBS-6-15

Device Problem Material Rupture (1546)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

As reported, a ultraxx nephrostomy balloon and set ruptured upon inflation.A 14 fr catheter was placed for nephrostomy and removed prior to the rupture.The sheath within the set was able to be used, and the biopsy was conducted with a pyeloscope.An unknown manufacturer's renal pelvis balloon was used to complete the procedure.The patient did not experienced any adverse effects due to this occurrence.

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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary.As reported, a ultraxx nephrostomy balloon and set ruptured upon inflation.A 14 fr catheter was placed for nephrostomy and removed prior to the rupture.The sheath within the set was able to be used, and the biopsy was conducted with a pyeloscope.An unknown manufacturer's renal pelvis balloon was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.The complaint device was returned for investigation.Upon inspection, a split in the balloon near the distal tip was noticed.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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.

• 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: 13862561
• MDR Text Key: 291852061
• Report Number: 1820334-2022-00434
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10827002460369
• UDI-Public: (01)10827002460369(17)241108(10)14336672
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• 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
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNBS-6-15
• Device Lot Number: 14336672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• 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