MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN EXTRACTION BALLOON V; CATHETER, BILIARY, DIAGNOSTIC

Model Number	B-V233P-A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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.Physician decided to place stent to protect against cystitis.Procedural note: indications for procedure:¿patient is status post ampullary adenoma resection in (b)(6) 2020¿(endoscopic and also with apc and rfa for residual tissue).She has been on surveillance since then.¿previous biopsies have been negative for any residual disease.¿¿she is here for¿ercp with periampullary biopsies.Procedure(s) performed: endoscopic retrograde cholangiopancreatography (ercp)¿, balloon sweeps.Cholangioscopy.Ercp¿findings: 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 patent 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 in to the major papilla and was advanced in to 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 mm¿inflated balloon multiple times.During balloon sweeps, we recognized that a small fragment of balloon catheter possibly broke and got sucked inside the duct.Using new balloon, cholangiogram showed small filling defect in the distal cbd.Balloon sweeps could remove it.Wire basket could 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 spybite and could not be retrieved.Images were taken.Viabil 8 mm x 4 cm was placed with excellent flow of contrast and few small stone fragments came out.Final fluoroscopic views of the hemidiaphragm revealed no free air.The duodenoscope was then completely withdrawn, insufflated air was aspirated, and the patient was extubated and returned to the recovery area in good condition having tolerated the procedure well.No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.Viabil placed.Possible small fragment 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: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 12525329
• Report Number: 12525329
• Device Sequence Number: 4102241
• Product Code: FGE
• UDI-Device Identifier: 04953170368707
• UDI-Public: (01)04953170368707(17)240331(10)14V
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021
• Report Date (Section F): 09/09/2021

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
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2021
• 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: Other; Required Intervention
• Patient Weight: 69
• Date Report Sent to FDA: 09/09/2021