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

Model Number	B-V233P-A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This event has been submitted by the importer on mdr# 2951238-2021-00432.
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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer.New information added to d10.The medwatch report has been attached.
Event or Problem Description
The customer provided additional information: it is unknown if the patient was intended to have the augmentin post-operatively or if it was ordered due to the un-retrieved balloon.No post-operative issues were documented.It is unknown if the subject device was inspected prior to use.It is unknown if there was a surgical delay due to the malfunction.On (b)(6) 2021, the patient returned for a endoscopic retrograde cholangiopancreatography (ercp) recheck due to the suspected retained small piece of balloon catheter in bile duct.Additionally, the patient had ercp with bile duct stent removal, bile duct stone removal, biopsy of ampulla and esophagogastroduodenoscopy with stomach biopsy.An olympus hd video duodenoscope was used for this procedure.Procedure and findings: egd: esophagus: normal mucosa stomach: multiple small ulcers with clean base or pigmented base ( likely nsaid induced).Random gastric biopsy done duodenum: normal mucosa ercp findings: the duodenoscope was inserted into the oropharynx under direct visualization and advanced smoothly into the stomach where the contents were suctioned.The scope was then further advanced through a patent pylorus to the second portion of the duodenum.The major papilla was visualized and showed previously placed non-olympus stent which was removed with snare bile duct was cannulated with balloon catheter.Cholangiogram showed multiple small filling defects in the distal bile duct.Balloon sweeps cleared sludge and follow up cholangiogram showed no filing defect in distal bile duct.At the level of cystic duct take there was large filling defect which was moved with 20 mm balloon.It was a large stone with successful extraction.Cystic duct was then cannulated over guidewire.Balloon catheter cholangiogram showed no filling defect , balloon sweep was done.Periampullary biopsies done ( history of ampullectomy for adenoma) 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.Impression: ercp bile duct stent removal.Ercp with bile duct stone removal, ercp with biopsy of ampulla.Egd with stomach biopsy ( ulcers seen in stomach).Plan: resume diet and home meds including plavix, will update patient biopsy results, and follow up in clinic in 6 weeks to discuss if continued surveillance or not, and ordered proton pump inhibitor.
Additional Manufacturer Narrative
This report is being submitted to provide additional information received from the customer.
Additional Manufacturer Narrative
Correction: e1.This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation, the results of the device history records (dhr) review, and applicable corrections.New information added to the following fields: e2, e3, h6, h10.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The device was manufactured in april 2021.A definitive root cause was not identified.The device referenced in this report has not been returned to olympus for evaluation.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to a force applied to the balloon.The following device handling issues may have caused the reported phenomenon: the instrument was operated abruptly or with excessive force when retrieving a foreign object.The balloon was inflated rapidly.The balloon was inflated larger than the diameter of the bile duct.A corner of bile duct stone damaged the balloon.The balloon was moved back and forth while the forceps elevator of the endoscope was raised.This caused the balloon to rub against the forceps elevator, damaging the balloon.The balloon was not completely deflated when the subject device was inserted into the endoscope.This caused the balloon which was not completely deflated to catch in the endoscope channel or forceps elevator, damaging the balloon.The instructions for use (ifu) states the following: "never use excessive force to operate the instrument.This could damage the instrument.Be sure to check the marks and indication 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 rapidly.The balloon may burst and the pieces could remain in the duct.This could result in mucous membrane damage.Do not inflate the balloon with too much air.Otherwise, the balloon may burst and the pieces could remain in the duct.Confirm that the balloon is completely deflated when inserting the instrument into the endoscope.If the balloon is not deflated completely, the distal end of the instrument may extend from the distal end of the endoscope abruptly.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage, and could damage the endoscope and/or instrument.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.Be sure to check the size of the treated duct under the x-ray image before inflating the balloon and use the premeasured syringe as described to obtain the desired balloon diameter.Besides, make sure to feed air carefully while observing the balloon under the x-ray image.Otherwise, the balloon may be inflated larger than the diameter of the bile duct, resulting in excessive dilation of the bile duct or mucous membrane damage.Or the balloon may burst, causing mucous membrane damage or the pieces remaining in the duct." olympus will continue to monitor the field performance of the device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12711579
• Report Number: 8010047-2021-13747
• Device Sequence Number: 20027291
• Product Code: FGE
• UDI-Device Identifier: 04953170275692
• UDI-Public: 04953170275692
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K091495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/29/2021; 10/29/2021; 06/01/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/01/2021; 11/08/2021; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS HD VIDEO DUODENOSCOPE.; UNKNOWN ENDOSCOPE.; UNKNOWN ENDOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 69 KG