MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BALLOON CATHETER

Model Number	B5-2C
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted to provide information reported by the customer and investigation findings.The device was manufactured in march 2022 physical evaluation of the suspect device: the tube was severed approximately 1035mm from the distal end.No parts at the proximal side such as the air feeding port were not returned.The balloon was inflated when it arrived.The fixed area in the rear end of the balloon was displaced to the distal side.A hole for inflating and deflating the balloon was exposed.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: do not use the balloon catheter to retrieve a calculus that is larger than the fistula or lumen size.Doing so could cause patient injury such as bleeding or mucous membrane damage.It could also burst the balloon or cause the balloon to become stuck in the fistula or lumen, resulting in the distal end of the instrument breaking off and remaining inside the fistula or lumen.The volume of the air in the balloon should not exceed the parameters specified in the tables in chapter 8, ¿specifications¿.Otherwise, the balloon may burst or may not deflate properly.When the balloon does not deflate, do not operate the balloon catheter with excessive force.Otherwise, the distal end of the instrument may break off and could remain inside the patient.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.If the balloon cannot be deflated, withdraw it using an appropriate method determined by the specialist.If an excessive force is applied on the balloon catheter when the balloon cannot be deflated, patient injury such as bleeding, mucous membrane damage, or edema may occur.It could also cause the balloon to burst or the distal end of the instrument to break off, which could remain inside the patient.Conclusion: the definitive cause of the reported events could not be established.Based on investigation findings, a likely mechanism causing the reported event might be the following: 1) a force beyond the strength resistance was applied to the balloon when retrieving foreign materials.2) the fixed area at the rear end of the balloon broke, and it was displaced to the distal end.3) a hole for inflating and deflating the balloon exposed.4) the balloon could not deflate.
Event or Problem Description
The customer reports during an unspecified procedure using a disposable balloon catheter, after inflation during the procedure, the balloon could not be deflated and it could not be removed.The balloon was cut from the base of the handle of the treatment instrument, replaced with a scope, and removed.Completed the procedure with the actual product with no patient impact.
Additional Manufacturer Narrative
This supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE BALLOON CATHETER
• Common Device Name: DISPOSABLE BALLOON CATHETER
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; 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: 15328786
• Report Number: 9614641-2022-00238
• Device Sequence Number: 12047340
• Product Code: EOQ
• UDI-Device Identifier: 04953170047398
• UDI-Public: 04953170047398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962901
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: B5-2C
• Device Lot Number: 23K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian