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

Model Number BD-400P-2080

Device Problem Deflation Problem (1149)

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

Event Type  malfunction  

Event Description

The customer reported that the balloon did not deflate completely and got stuck in the scope while withdrawing it from the scope.The reported issue occurred during a therapeutic esophageal dilation procedure.Reportedly, the balloon was cut from the scope, but dilation was completed first.The reported issue did not affect the outcome of the procedure.There was no report of patient or user injury due to the event.

Manufacturer Narrative

H4 device manufacturer date: date of manufacture cannot be determined since the lot number was not provided.The subject device has not been returned to olympus for further evaluation and testing.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.H3 other text : device not returned.

Manufacturer Narrative

Correction: the lot number was inadvertently omitted from the initial report.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 root cause of the event was unable to be identified.The investigation concluded that this nonconformance observed in this complaint 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: OESOPHAGEAL BALLOON CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17619512
• MDR Text Key: 321950837
• Report Number: 3011050570-2023-00125
• 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
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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: 383361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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
• Treatment: MAJ-1740 EZDILATE¿ INFLATION DEVICE