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

This supplemental report is to inform that upon further review, this event has already been reported on medwatch 3011050570-2023-00125 (patient identifier (b)(6)).Refer to this file for supplemental information related to this event.

• 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: 17646949
• MDR Text Key: 322436468
• Report Number: 3011050570-2023-00128
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-2080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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