MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 18-19-20

Model Number BD-400P-2080

Device Problem Deflation Problem (1149)

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

Event Date 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Event Description

An olympus sales representative (rep) reported that the customer¿s olympus ezdilate balloon dilator did not deflate completely, and the customer was unable to retrieve into the scope.According to the rep, it had to be cut off at the tip of the scope.Reportedly, there was no patient harm as a result of this event.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This report is being submitted to capture additional information provided by the initial reporter.That information is located in b5.Should further information be provided prior to the conclusion of the investigation another supplemental report will be provided.

Event Description

Additional information was received from the customer on (b)(6) 2023.The customer confirmed that the issue occurred at the end of the procedure once they were completed and removed the balloon.The condition of the patient was not impacted by the failure.The type of procedure being performed was an egd with dil.The procedure was able to be completed with the same device.The procedure was not prolonged.The patient¿s anesthesia or sedation was not extended.There was no medical intervention required.It is unknown as to whether any other devices were connected to the device when the failure occurred.The device has been returned per the customer.The patient demographics and pre-existing conditions are not available.

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, this event was categorized as a process defect.An exhaustive revision of the process was completed, founding that occlusion partial or total was generated in the proximal bonding station due to misalignment of the d-mandrel or mandrel during the preparation for bonding process.The operator has not enough visibility to ensure the correct position of the d-mandrel or mandrel, causing melting material smearing occluding partial or total the diameter of the extrude.Causing two events, the first is the diameter is completely occluded which would prevent the balloon from inflating.And the second event would be that the diameter is partially occluded which would cause it to take longer to inflate or deflate.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Type of Device: BALLOON
• 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: 17540673
• MDR Text Key: 321148927
• Report Number: 3003790304-2023-00320
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00821925033214
• UDI-Public: 00821925033214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-KNQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-2080
• Device Lot Number: 376574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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