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

Model Number G30365

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an ultraxx nephrostomy balloon set was dilated in a pcnl to establish a nephrostomy tract into the kidney for stone manipulation, however, the sheath would not advance.A second attempt was made at an alternative puncture site where the sheath would not advance again.The physician stated there was significant space between the outer diameter of the balloon and the inner diameter of the sheath despite complete inflation of the balloon.The case was aborted and the patient¿s stones remain within the kidney.The physician has referred the patient to another facility for a probable pcnl as further treatment.To date, no known adverse consequences to the patient resulted from this incident.

Event Description

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

Manufacturer Narrative

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

Manufacturer Narrative

Investigation ¿ evaluation the complaint device was not returned for an evaluation.Photographs were provided.A physical analysis of the device could not be performed.A document based investigation was a conducted.A review of provided photos, complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and trends was performed.Three photos provided.Photos confirm device information and the sheath stuck over balloon.A review of the device history record showed there were no non-conformances associated with the complaint device lot number.A review of complaint history revealed this the only complaint for lot 8424205.As found in the instructions for use (ifu): inflation device preparation and balloon inflation 11.Advance the sheath over the inflated balloon and into the proper position.Note: the tolerances of the sheath and inflated balloon are very close.If resistance is encountered when advancing the sheath, it may be necessary to decrease balloon inflation to facilitate sheath passage.The unbs-10-15 is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.It is not clear if the physician attempted to pre-inflate the balloon.The ifu cautions against pre-inflating the balloon.There is no information regarding the preparation of the device.The ifu states: prior to use, remove the inner protective tubing from the clear amplatz sheath.Back load the amplatz sheath over the balloon and secure it to the sheath lock at the proximal end of the catheter.Verify that the sheath is properly oriented, with the beveled tip distal on the balloon catheter.The complaint device was not returned.The cause of the sheath being unable to advance over the balloon is unknown.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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 has been obtained.

• 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: 7438557
• MDR Text Key: 105753153
• Report Number: 1820334-2018-00823
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002303652
• UDI-Public: (01)00827002303652(17)201206(10)8424205
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: G30365
• Device Catalogue Number: UNBS-10-15
• Device Lot Number: 8424205
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 06/21/2018; 11/30/2020
• Supplement Dates FDA Received: 06/22/2018; 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention