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

Model Number	B-V233P-A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to olympus via medwatch report (b)(4).The physician was performing an endoscopic retrograde cholangiopancreatography (ercp), balloon sweep and cholangioscopy with periampullary biopsies procedure when the olympus device malfunctioned.While doing balloon sweep of common bile duct with over wire multi-3 v plus balloon the actual balloon separated from the device and was left inside papilla.After multiple attempts, retrieval was unsuccessful and the physician placed a stent to prevent cystitis.Ercp findings/procedure: the duodenoscope was inserted into the oropharynx under direct visualization and advanced smoothly into the stomach where the contents were suctioned.A cursory view of the gastric mucosa was normal.The scope was then further advanced through a pendent pylorus to the second portion of the duodenum.The major papilla was visualized and appeared small and flat.No mass or growth was seen.A biliary retrieval balloon preloaded with 0.025 inch guidewire was inserted into the major papilla and was advanced into the bile duct and intrahepatic ducts.Occlusion cholangiogram did not show any filling defect or stricture.Cystic duct was patent.The bile duct was swept with 11.5 and 15 cm inflated balloon multiple times.During balloon sweeps, we recognized that a small fragment of balloon catheter possible broke and got sucked inside the duct.Using new balloon, cholangiogram show small filling defect in the distal cbd.Balloon sweeps could remove it.Wire basket can not remove it.Cholangioscopy was done.An abnormal appearing intraductal content was seen, which could have been likely the fragment catheter piece but it went upstream during passing non-olympus biopsy forceps and could not be retrieved.Image were taken.A non-olympus biliary endoprosthesis stent (8 mm x 4 cm) was placed with excellent flow of contrast and few small stones fragments came out.Final fluoroscopic views of the hemidiaphragm reveled no free air.The duodenoscope was then completely withdrawn, insufflated air was aspirated, and the patient was extubated and returned to the recovery area in good condition having tolerated the procedure well.No immediate post procedure complications were observed.Intraoperative antibiotic dose was given.Impression: ercp, balloon sweeps, small stones removal.Non-olympus stent placed.Possible small fragments of balloon catheter in the duct.(unsuccessful removal) plan: repeat ercp for stent removal, cleaning duct and periampullary biopsies in 6-8 weeks.Augmentin oral for 4 days.

• 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: 12711534
• Report Number: 2951238-2021-00432
• Device Sequence Number: 17169656
• Product Code: FGE
• UDI-Device Identifier: 04953170275692
• UDI-Public: 04953170275692
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2021
• Report Date (Section F): 10/05/2021

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-V233P-A
• Device Lot Number: 14V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 69