MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN EXTRACTION BALLOON V

Model Number	B-V243Q-A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was manufactured on october 2023 based on the provided lot information, however an exact date is unknown (h4).Three attempts were performed to obtain additional information, but no response was received from the customer.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-00229.
Event or Problem Description
It was reported the single use 3-lumen extraction balloon popped inside the patient during an unspecified procedure.Ears, nose, throat (ent) needed to re-intervene/retrieve the balloon fragments left behind in the patient.Additional information regarding the procedure and device retrieval was requested, but not provided at the time of this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to move the related importer number from h11 to h10.
Event or Problem Description
It was reported, that the balloon pieces fell into the patient¿s common bile duct, during an endoscopic retrograde cholangiopancreatography procedure (ercp).The patient¿s health condition is reportedly ¿fine¿.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.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, that the balloon was scratched, due to stress being applied to it, causing the balloon to break from the scratch, when it was inflated.The stress was likely, due to the following factors: 1.The balloon rubbed against the forceps elevator, because the balloon part was moved back and forth with the forceps elevator raised.2.Since, the balloon was not fully deflated when inserting the item into the endoscope, the slack balloon got caught in the endoscope channel and the forceps elevator, increasing the resistance.The broken balloon pieces required retrieval from the body.However, the root cause of the event could not be determined.The event can be detected/prevented, by following the instructions for use (ifu), which state: ¿be sure to check the readings on the premeasured syringes to see if its maximum volume matches, the maximum diameter of the inflated balloon, indicated on the air-feeding port.An improper combination of the premeasured syringe and the balloon catheter may cause excessive inflation of the balloon, resulting in patient injuries such as tissue inflammation.This may also cause damage to the instrument¿.¿do not inflate the balloon with any syringes other than the premeasured syringes included in the package.Otherwise, the balloon may burst and the pieces could remain in the duct¿.¿do not inflate the balloon rapidly.Otherwise, the balloon may burst and the pieces could remain in the duct¿.¿inflate the balloon only with air.Inflation with anything other than air may, hinder expansion and contraction of the balloon¿.¿do not inflate the balloon with too much air.Otherwise, the balloon may burst and the pieces could remain in the duct¿.¿do not operate the instrument abruptly or with excessive force when retrieving a foreign object.Otherwise, patient injury such as bleeding, mucous membrane damage or edema may occur¿.¿be sure to check the size of the treated duct under the x-ray image before inflating the balloon.And use the premeasured syringe as described to obtain the desired balloon diameter.Besides, make sure to feed air carefully while observing, the balloon under the x-ray image.Otherwise, the balloon may be inflated larger than the diameter of the bile duct.Resulting, in excessive dilation of the bile duct or mucous membrane damage or the balloon may burst, causing mucous membrane damage or the pieces remaining in the duct¿.This supplemental report includes information received from the customer.B5 updated accordingly.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Common Device Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19144698
• Report Number: 9614641-2024-00941
• Device Sequence Number: 7800458
• Product Code: LQR
• UDI-Device Identifier: 04953170368721
• UDI-Public: 04953170368721
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091495
• 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): 07/03/2024

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: B-V243Q-A
• Device Lot Number: 3XV
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/05/2024; 06/19/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/07/2024; 07/03/2024
• 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