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

Catalog Number UNBS-8-15-CS

Device Problems Inflation Problem (1310); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/06/2018

Event Type  Injury  

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

It was reported, during a percutaneous nephrolithotomy (pnl) procedure against right kidney calculus, the ultrax nephrostomy balloon and set was used to dilate nephrostomy.The pnl was performed from the lesion where a previous nephrolithotomy was performed due to kidney calculus, therefore there was scarring at nephrostomy.There was severe stenosis (in the form of ring) at scarring lesion, so it was difficult to place the wire guide after puncture.The balloon was inserted and dilation attempted, however, the balloon would not inflate enough.It was difficult to dilate even with strong pressure, and decision was made to stop.No balloon rupture/damage at this time.During retrieval of the balloon, there was resistance, but they managed to remove the device with "torquing".The balloon and catheter came out of the patient's body damaged.After the procedure, it was confirmed that there was separation of the catheter 2-3cm from the distal tip.At x-ray after surgery, the radiopaque marker metal band-like material of the catheter was clearly observed in the patient¿s body.The drainage balloon was placed through nephrostomy to finish the procedure.Pnl itself was unsuccessful.Computerized tomography (ct)/checkup are planned at a later date for confirmation.It is likely that the ruptured section is inside of retroperitoneal space or inside of kidney parenchyma.Additional information was received on (b)(6) 2018: pnl was performed.Pnl itself was completed successfully, however the part of the balloon could not be retrieved since it seemed placed outside of the kidney.The patient was discharged on (b)(6) 2018.Additional information was received on (b)(6) 2018: there was no kidney stone at check-up.The separated piece of the device remains in the patient's body.Additional information was received on (b)(6) 2018: there is no update on the patients' condition, awaiting the patient's outpatient visit.Depending on the patients condition, a decision to retrieve the separated part of the device will be made.

Event Description

Additional information received 21nov2018.The sales representative visited the physician and obtained additional information as reported, the patient visited for check ups, and it was confirmed that the patient's condition is stable, and there is no sign of infection.Due to the patient's condition, the physician decided not to perform the open surgery since the risk of the surgery is high.The separated tip will be left in the patient's body and the patient will be followed up.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of the instructions for use, quality control data, and specifications.One device was returned for investigation.A visual examination noted the distal end of the balloon has separated approximately 5.5 cm from the distal tip.The separated balloon material was not returned.There is 12 cm of balloon material remaining on the catheter.The balloon material is accordion-like in appearance.The complaint was confirmed based on the device analysis.This device is inspected visually and functionally for cracks and fractures by manufacturing and quality control.The device history record review could not be performed as the lot number of the complaint device was not provided.A search of complaint records for the complaint device lot was unable to be performed as the lot number of the device was not provided.The instructions for use (ifu) states the proper warnings, precautions, and instructions for use.The instructions provide the following information in the section: balloon deflation and withdrawal deflate the balloon by syringe aspiration.Aspirate the balloon completely before gently removing the device.Removal of the catheter is facilitated by rotating the shaft counterclockwise during withdrawal.There is no information as to whether the ifu was followed for the device preparation and if the sheath was properly oriented with the beveled tip distal on the balloon catheter.Additionally, there is no information surrounding deflation of the device or if it was allowed to fully deflate.The patient¿s anatomy consisted of stenosis and scarring lesion from a previous nephrolithotomy.Based on the current information, the most probable causes of this event are patient anatomy, medical procedure, user technique or device failure related.Based on information available a definitive conclusion cannot be determined.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

There has been no new information received since the last report was submitted.

Manufacturer Narrative

Additional information: event and concomitant medical products.

Event Description

Additional information was received (b)(6) 2018: the sales representative visited the facility and obtained additional information from the doctor and nurse.The separated catheter tip is still within the patients' body.It is possible that they may leave the separated tip in the patients' body, depends on the patients' general condition/risk of the surgery.The physician is considering the operation, it is assumed that open surgery is needed.The patient has reduplicative urinary calculosis, therefore the removal of the separated part will be considered during the next percutaneous nephrolithotomy (pnl) procedure.There is no adverse effect to the patient.

• 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: 7889183
• MDR Text Key: 120718124
• Report Number: 1820334-2018-02706
• Device Sequence Number: 1
• Product Code: LJE
• 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,Followup,Followup
• Report Date: 11/26/2018

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 Catalogue Number: UNBS-8-15-CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/03/2018; 10/31/2018; 11/19/2018
• Supplement Dates FDA Received: 10/04/2018; 11/05/2018; 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR