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

Catalog Number UNBS-8-15

Device Problem Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Customer name and address: postal code: (b)(4).Device evaluated by mfg: other (81) - device evaluation has begun; however, a conclusion is not yet available.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, during a percutaneous nephrolithotripsy using an ultraxx nephrostomy balloon and set, the supplied sheath could not be advanced smoothly over the balloon catheter.The catheter moved forward during attempted sheath advancement causing "damage" to the renal pelvis.No information regarding the severity or type of damage to the patient has been received.Additional details regarding patient outcome and event details have been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction- b1, h1: there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.Furthermore, there is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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

Additional information was received on 12nov2020: the user inserted the device into the patient and inflated the balloon.The user attempted to advance the supplied sheath over the balloon but could not advance it smoothly.The balloon catheter moved forward during attempted advancement of the sheath, and the catheter tip damaged mucosa of the renal pelvis and bleeding was confirmed.He removed the balloon outside of the patient and inflated the balloon on the table and tried to advance the sheath over the balloon, but it would not be advanced.The user then elected to replace the device with another of the same type.The nephrostomy was successfully completed by placing a nephrostomy catheter.No tortuous anatomy was noted.The user performed no treatment for the bleeding from renal pelvis mucosa.As of (b)(6) 2020, no bleeding was observed, and the patient was in stable condition.

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON AND SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10790937
• MDR Text Key: 214751391
• Report Number: 1820334-2020-02014
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10827002460246
• UDI-Public: (01)10827002460246(17)211207(10)9366595
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2021
• Device Catalogue Number: UNBS-8-15
• Device Lot Number: 9366595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other