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

Model Number	BD-400P-1880
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported during an unknown procedure, the balloon was inflated to 18mm and it ruptured inside the patient.The balloon fragments were removed from the patient with an unknown instrument 'to the best of their knowledge.' multiple attempts requesting additional information have been unsuccessful.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Additional information received from the customer: the intended procedure was an endoscopy to treat a stricture.The balloon burst in the middle of the procedure when the physician was inflating from 17 to 18mm.The balloon had a hole and did not fragment and only water fell into the patient.There was no balloon debris in the patient as initially reported.The intended procedure was completed at that time as the stricture had been resolved at 16-17mm and there was no delay in the procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer and the legal manufacturer's investigation.New information added to the following fields: b5, d10, h4, h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was determine the probable cause may be due to using improper inflation device or customer error.The balloon may be damaged during insertion or retrieval either through scrapping or gouging when passing through the endoscope or on staples, if present, in the patient¿s intestine.This may cause it to burst during inflation or deflation.All balloon catheters are 100% leak tested during the manufacturing process.Any leaking balloons are scrapped.Olympus will continue to monitor complaints for this device through regular trending activities and take action if triggered by osta qms procedure.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15287688
• Report Number: 3005975494-2022-00031
• Device Sequence Number: 14026322
• Product Code: KNQ
• UDI-Device Identifier: 00821925033207
• UDI-Public: 00821925033207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT-KNQ
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BD-400P-1880
• Device Lot Number: 345522
• Was Device Available for Evaluation?: No
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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: GIF-H190, SERIAL (B)(6) ; UNKNOWN ENDOSCOPE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown