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

Model Number BD-400P-2080

Device Problem Deflation Problem (1149)

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

Event Date 05/22/2023

Event Type  malfunction  

Manufacturer Narrative

Communication with the customer via the company representative reported that the subject device is not returning, the customer discarded the device.In addition, in a follow up communication, it was reiterated that the balloon did not fully deflate.Upon removing, the water gathered at the tip preventing it from it being able to be pulled from the scope.In addition, per the report response, the maj-1740 (inflation device) was not used during the procedure.Customer used a cook medical syringe (third party), it was filled with 35cc¿s.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported the balloon would not deflate and had to be cut.The issue occurred post diagnostic dilation procedure when trying to remove the balloon through the scope from the patient.There was no patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation.Customer returned two devices.The two device returned per the note is for patient identifier (b)(6).Visual inspection noted that the first device was returned with the balloon cut off and the balloon returned.The second device was returned with the balloon cut off and the balloon not returned.In both instances, the complaint can be confirmed as the balloon is confirmed to not be attached to the device.This evaluation is for the device with balloon returned.Device evaluation, the following were noted : the device was returned with the balloon cut off.Catheter lot noted to be 365586.The balloon was returned and was cut off.As the balloons were cut, the devices cannot be tested.A definitive root cause cannot be determined at this time.The original equipment manufacturer (oem) has been informed for further evaluation investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide a correction with information inadvertently left out (h4 and h7).

Event Description

No error messages that may have been observed as a result of the failure.The reported problem did not affect the diagnostic or therapeutic outcome of the procedure.The procedure did not need to be completed with another device.No medical intervention (i.E.Treatment outside the scope of the procedure) required as a result of the reported problem.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.Additionally, to provide a correction to the initial (e1- name, email and phone number, e2, and e3).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, it is likely the suggested event occurred due to 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.However, the root cause of the suggested event could not be determined.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 BALLOON DILATOR
• 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: 17140466
• MDR Text Key: 317784250
• Report Number: 3003790304-2023-00238
• 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,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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: 365586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2023
• 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: FB-210U(FORCEP)LOT # 2SAY16; MAJ-1740 LOT 96379131; MEDICAL SYRINGE (COOK MEDICAL); SCOPE (UNKNOWN MODEL)