MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 16-17-18; BALLOON DILATATION CATHETER

Model Number BD-400P-1880

Device Problem Deflation Problem (1149)

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

Event Type  malfunction  

Manufacturer Narrative

The device is pending return for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported to olympus that when using an ez dilate balloon dilator, it would not deflate properly.This has happened on more than one occasion.The event occurred during the procedure.There was no patient harm associated with the event.This report is linked to patient identifiers: (b)(6).

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, a physical device inspection could not be performed as it was reported that the customer has discarded the device.However, 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• Type of Device: BALLOON DILATATION 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: 17470512
• MDR Text Key: 320662982
• Report Number: 3011050570-2023-00110
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00821925033207
• UDI-Public: 00821925033207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-1880
• Device Lot Number: 382350
• Was Device Available for Evaluation?: No
• 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: 03/30/2023
• 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