MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN EXTRACTION BALLOON V

Model Number	B-V243Q-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation and therefore the cause of the reported event cannot be determined.As a preventive measure, the instruction manual provides several warning statements: 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.
Event or Problem Description
It was reported that during an unspecified procedure, the balloon burst when trying to withdraw it from the pancreatic duct.The balloon was removed from the patient and was intact upon retrieved.There was no patient harm or injury reported due to the event.

• Brand Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Common Device Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9459379
• Report Number: 8010047-2019-04287
• Device Sequence Number: 2159801
• Product Code: LQR
• UDI-Device Identifier: 04953170279515
• UDI-Public: 04953170279515
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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: B-V243Q-A
• Device Lot Number: 95V
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2019
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1