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

Catalog Number UNBS-6-15-CS

Device Problem Material Rupture (1546)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

As reported, during a percutaneous nephrolithotomy (pcnl), an ultraxx nephrostomy balloon and set was inflated with saline to 22 to 23 atmospheres and ruptured upon the first inflation.The access site was the kidney "in the back" and there was no report of any tortuous, calcified, or scarred anatomy.The device was removed and the procedure was completed with another same type device.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: urology coordinator.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.Upon further investigation, this event is not reportable.This event does not meet the criteria for a reportable malfunction or serious injury.An mdr guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote.A detailed review of complaint history using a validated report revealed that there have been no deaths or serious injuries, per 21 cfr part 803.3, due to a ultraxx balloon catheter¿s balloon material being compromised (rupture/burst, pinhole, cut, etc.), from 01jan2019 through 10aug2022.Therefore, cook will cease malfunction reporting for events where a ultraxx balloon catheter¿s balloon material was compromised (rupture/burst, pinhole, cut, etc.).The recurrence of a serious injury or death for the same malfunction will trigger the resumption of mandatory reporting, per 21 cfr part 803.50.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 15026233
• MDR Text Key: 304793552
• Report Number: 1820334-2022-01213
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10827002460376
• UDI-Public: (01)10827002460376(17)241215(10)14421319
• 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: 11/03/2022

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 Catalogue Number: UNBS-6-15-CS
• Device Lot Number: 14421319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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
• Patient Sex: Female