MAUDE Adverse Event Report: GYRUS ACMI, INC. INFLATION DEVICE (DISPOSABLE) FOR EBD; CATHETER/OVERTUBE BALLOON INFLATOR, SINGLE-USE

Model Number MAJ-1740

Device Problem Inflation Problem (1310)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned 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 that during an unknown procedure, the inflation device for endoscopic balloon dilatation was being used.It was primed with sterile water to the fill line and attached to a third-party cre fixed wire balloon in 2 millimeter (mm)/13.5mm/15mm size.Upon dilation.It was noted after the third stretch that the balloon would no longer inflate.The balloon was deflated and removed.A new balloon in 12mm/13.5mm/15mm size was reinserted and upon inflation to 13.5mm, it lost pressure and the patient even remarked that she could feel that.The balloon was immediately removed and was noted to have burst.There was no harm or user injury reported due to the event.This event is reported under the following patient identifiers: (b)(6) - inflation device (1/2).(b)(6) - inflation device (2/2).

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer.(b3/date of event, b5/event description, e2/health professional, and e3/occupation ).

Event Description

The patient did not experience any pain but did feel the balloon pop.There were no retained fragments from the balloon bursting.The event occurred during the therapeutic procedure (esophageal dilatation) and was completed with a similar device.There was a 10¿15-minute delay to switch devices.There was no harm or user injury reported due to the event.This event is reported under the following patient identifiers: (b)(6) - inflation device (1/4) (b)(6) - inflation device (2/4) (b)(6) inflation device (3/4) (b)(6)- inflation device (4/4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the original equipment manufacturers (oem) final investigation and a correction to d4.D4: the lot number is corrected to 'unknown' as the oem could not confirm the lot number provided.The device history record was unable to be reviewed for this device since the lot number could not be confirmed.Therefore, the device manufacturer date is unknown.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor complaints for this device.

• Brand Name: INFLATION DEVICE (DISPOSABLE) FOR EBD
• Type of Device: CATHETER/OVERTUBE BALLOON INFLATOR, SINGLE-USE
• 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: 17406577
• MDR Text Key: 319974312
• Report Number: 3003790304-2023-00295
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00856877002537
• UDI-Public: 00856877002537
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K032840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1740
• Device Lot Number: 28064489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 08/28/2023; 04/16/2024
• Supplement Dates FDA Received: 09/01/2023; 04/26/2024
• 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