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

Model Number	BD-400P-2080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned as it was discarded by the customer.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
An olympus representative reported on behalf of the customer, that an ez dilate balloon dilator (fw) 18-19-20, burst inside the patient when inflated to 20mm.The event occurred during the therapeutic procedure (esophagogastroduodenoscopy (egd) with esophageal dilation) and was completed with the same device.This is the ninth occurrence from this lot.There was no procedural delay, or no patient harm associated with the event.
Event or Problem Description
The patient was under monitored anesthesia care (mac) during the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation with correction to the initial with information inadvertently left out.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: the device was found in two pieces as it appears that the balloon has been cut off approximately an inch from the base.In addition, a large vertical tear can be found along the entire clear balloon.The wire was also returned and found to have a few kinks, however, it is unlikely that the customer used the device with the noticeable kinks and more likely that the kinks were created after procedure.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 the seam connecting the two halves of the balloon is not correct.However, the subject device was not returned and the root cause of the event could not be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to b5 with information inadvertently left out.
Event or Problem Description
This complaint is related to additional 8 complaints: (b)(4).

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Common Device Name: 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: 17558797
• Report Number: 3011050570-2023-00119
• Device Sequence Number: 14359091
• Product Code: KNQ
• UDI-Device Identifier: 00821925033214
• UDI-Public: 00821925033214
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: BD-400P-2080
• Device Lot Number: 383359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 12/28/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/28/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAJ-1740 INFLATION DEVICE (DISPOSABLE) FOR EBD
• Patient Sex: Unknown