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

Model Number	B-V243Q-A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported during an endoscopic retrograde cholangiopancreatography (ercp), the extraction balloon catheter broke inside the patient while the physician attempted to remove stones.It was reported approximately 30 cm of catheter remained inside the patient's common bile duct while the remaining device was pulled through the scope.The physician used foreign body retrieval graspers to remove the distal portion of the device which had dislodged inside the patient.The device failure will require a follow up ercp to remove the stones inside the patient.A request for additional information is in progress.
Additional Manufacturer Narrative
The device referenced in this report has not yet been received by olympus for evaluation (although it is anticipated).The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer was asked if there were any anatomical or procedural difficulties which could have contributed to the reported event.The customer stated the patient had a bile duct stone larger than normal, therefore the physician decided to incorporate sphincteroplasty to dilate the patient's ampulla.A follow-up ercp was needed to remove the stone; however it could not be confirmed by the reporter if the procedure had been completed.The suspect device was inspected prior to the (b)(6) 2022 procedure, and no anomalies were found.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer and the results of the device evaluation.New information was added to the following fields: b5, d9, h3, h6, h10.The device was returned to olympus for evaluation and the customer's allegation was confirmed.A visual inspection of the returned device found the guide wire sheath was broken apart from the tube sheath, exposing internal elements.In addition, the balloon from the distal end was discolored and kinks were noted with the tube sheath.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
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.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the incident was likely caused by the following sequence of events: 1) the forceps elevator was raised too high during the calculus lithotomy procedure, or a bending force was applied to tube 1 which was extended from the endoscope.2) then, tube 1 was bent.3) the insertion portion was pulled in situation 2.4) a force beyond resistance was applied to the tube.This caused tube 1 to detach from tube 2.5) then, tube 1 dropped off into the patient body.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿never use excessive force to operate the instrument.This could damage the instrument.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.Do not pull the tube with excessive force.Otherwise, the balloon may burst, and the pieces could remain in the duct.This could result in mucous membrane damage.If it is difficult to withdraw the balloon, deflate it before withdrawing.If resistance is too strong and withdrawal is difficult, adjust the angle of the endoscope until the instrument can be withdrawn smoothly.Forcible withdrawal of the instrument could damage the instrument and/or endoscope.When using an endoscope equipped with a forceps elevator, do not withdraw the instrument from the endoscope if the forceps elevator is up.This could damage the instrument.¿ 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; aomori, kuroishi-shi 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15251841
• Report Number: 9614641-2022-00152
• Device Sequence Number: 6447605
• Product Code: LQR
• UDI-Device Identifier: 04953170368721
• UDI-Public: 04953170368721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2022

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: B-V243Q-A
• Device Lot Number: 25V
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 08/21/2022; 10/03/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/13/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown