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 returned b-v243q-a extraction balloon v lot # 95v 13 was evaluated for ¿balloon burst¿ when trying to withdraw from the pancreatic duct issue.Visual inspection was performed on a received condition and was unable to test or inspect the balloon on the device as the subject balloon was missing and was not returned.The tube is inspected and found that it was severely kinked from the distal end.Based upon the evaluation and investigation results, the likely cause of the balloon burst and severely kinked tube of the device is due to mishandling.
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 removal.There was no patient harm or injury reported due to the event.
Additional Manufacturer Narrative
The returned b-v243q-a extraction balloon v lot# 95v 13 was evaluated for ¿¿balloon burst¿ issue.Visual inspection was performed on the received condition and were unable to test or inspect the device as the balloon was not returned.The tube is severely kinked from the distal end side.In summary, based on the evaluation and visual inspection results, the cause of the severe kink on the tube is due to mishandling.

• 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: 9452610
• Report Number: 8010047-2019-04247
• Device Sequence Number: 2158841
• 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,Followup
• Report Date (Section B): 12/27/2019

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 13
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1