MAUDE Adverse Event Report: GYRUS ACMI, INC. PCNL BALLOON, 10MM(30FR) X15CM; BALLOON DILATION CATHETER

Model Number BPCN1015

Device Problem Burst Container or Vessel (1074)

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

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was sent to olympus for evaluation.The balloon was returned in a small tied up plastic bag.The balloon was removed from the bag and inspected.The device was very clearly used as it had remnants of blood and other debris.The balloon was very clearly burst, and because of this the device was unable to be function tested.No pieces of the balloon appear to be detached or missing.The luer of the balloon appeared to have no other damage.The balloon burst was confirmed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported the balloon burst during a procedure.Maximum atmosphere 17 was used and the balloon did not fold out properly.The user suspected the inflation device was incorrect.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.There was no harm or user injury reported due to the event.This report is for the balloon.The balloon inflation device (model binf2530) is being reported on the medwatch with patient identifier (b)(6).

Event Description

Additional information was received from the customer.The procedure was a percutaneous nephrolithotomy which was completed with a device from another manufacturer.There was no effect on the patient due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information that was received from the user facility regarding the reported issue.Information provided in b3 and b5.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the gauge being inaccurate was unable to be determined and the root cause of the balloon burst was unable to be confirmed.The final root cause of the burst was unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: PCNL BALLOON, 10MM(30FR) X15CM
• Type of Device: BALLOON DILATION CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15945986
• MDR Text Key: 308176311
• Report Number: 3003790304-2022-00328
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00821925033023
• UDI-Public: 00821925033023
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2023

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: BPCN1015
• Device Lot Number: 22020195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 04/12/2023
• Supplement Dates FDA Received: 12/16/2022; 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Treatment: BINF2530: OLYMPUS BALLOON INFLATION DEVICE