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

Model Number	BD-410X-2055
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned to olympus for evaluation, as the device has been discarded by the user facility staff after the procedure.The cause of the reported event cannot be conclusively determined.The investigation in ongoing, and if new information becomes available later, this report will be supplemented accordingly.
Event or Problem Description
An olympus territory manager reported a complaint on behalf of the customer, stating that during an unspecified procedure, the customer had six balloons popped inside of patients.They have all been 18-20mm balloons and believed to all wire-guided.The balloons were completely retrieved from the patient.There was no patient harm reported.This is 2 of 6 reports: #1 of 6: (b)(6) | model bd-410x-2055 | lot #354263, #2 of 6: (b)(6) | model bd-410x-2055 | lot #345028, #3 of 6: (b)(6) | model bd-410x-2055 | lot # ¿unknown¿, #4 of 6: (b)(6) | model bd-410x-2055 | lot # ¿unknown¿, #5 of 6: (b)(6) | model bd-410x-2055 | lot # ¿unknown¿, #6 of 6: (b)(6) | model bd-410x-2055 | lot # ¿unknown¿.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation results, which stated that no physical evaluation was performed, as the subject device was discarded by the customer.As a result, definitive root cause cannot be determined.The legal manufacturer further stated that the likely cause of the reported phenomenon is due to the insertion through scrapping or gouging when passing through the endoscope.The dhr for the finished device was reviewed and no abnormalities in documentation or process were noted.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct multiple fields.See corrections to: b1, b2, h1, and h6.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 18-19-20
• Common Device Name: OESOPHAGEAL BALLOON CATHETER
• 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: 16005598
• Report Number: 3003790304-2022-00341
• Device Sequence Number: 6738228
• Product Code: KNQ
• UDI-Device Identifier: 00821925033276
• UDI-Public: 00821925033276
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K180086
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2023

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-410X-2055
• Device Lot Number: 345028
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 03/15/2023; 04/10/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 04/14/2023; 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown