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

Model Number G46023

Device Problems Material Separation (1562); Difficult to Open or Remove Packaging Material (2922)

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

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.

Event Description

As initially reported, during retrograde intrarenal surgery (rirs), the inner protective tubing could not be removed from the sheath of an ultraxx nephrostomy balloon.The issue with this device was discovered prior to making contact with the patient and it was not used.A new same type device was used to complete the procedure.The device was returned to the manufacturer 08mar2022 with the balloon in two separate pieces.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

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, unchanged, or unavailable.Event description: as initially reported, during retrograde intrarenal surgery (rirs), the inner protective tubing could not be removed from the sheath of an ultraxx nephrostomy balloon.The issue with this device was discovered prior to making contact with the patient and it was not used.A new same type device was used to complete the procedure.The device was returned to the manufacturer 08mar2022 with the balloon in two separate pieces.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, and quality control data.One ultraxx nephrostomy balloon was returned for investigation.The device was returned in an open packaging with the balloon in two separate pieces.The point of separation for the balloon was approximately 19cm from the distal end.The point of separation had a stretched appearance.The orange protective sheath was in place over the balloon and a dried unknown substance (presumably the fluid used for inflation) was found inside the sheath.The dried unknown substance looks to have hardened and as a result trapped the balloon inside the sheath.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.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 instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿warnings ¿ always inflate the balloon with sterile liquid.Never inflate with air, carbon dioxide or any gas.¿ do not over inflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.¿ instructions for use inflation device preparation and balloon inflation note: 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.¿ 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.The complaint of the inner tubing being unable to be removed from the sheath was confirmed.It was also noted in the device failure analysis that the balloon had separated.The cause for this complaint was unable to be determined.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The appropriate personnel have been notified, and we will continue to monitor 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.

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON
• 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: 13876061
• MDR Text Key: 294620213
• Report Number: 1820334-2022-00444
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002460232
• UDI-Public: (01)00827002460232(17)240827(10)NS14175688
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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 Model Number: G46023
• Device Catalogue Number: UNB-6-15-CS
• Device Lot Number: NS14175688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 52 KG