MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (FW) 6-7-8; OESOPHAGEAL BALLOON CATHETER

Model Number	BD-400P-0880
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	01/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature "case report endoscopic tissue shielding with polyglycolic acid sheet, fibrin glue,and endoclip for perforation during balloon dilation for esophageal stricture after endoscopic submucosal dissection."     literature summary: esophageal endoscopic submucosal dissection can cause esophageal strictures.Endoscopic balloon dilation is the standard treatment for esophageal strictures, but has complications, including perforation, and sometimes requires surgery.We report a case of perforation during endoscopic balloon dilation for esophageal stricture secondary to esophageal submucosal dissection that was successfully treated conservatively.A 66-year-old man with superficial carcinoma in the upper thoracic esophagus underwent circumferential endoscopic submucosal dissection with local steroid injections.Endoscopic balloon dilation was performed weekly for esophageal stricture.However, during the sixth procedure, an attempt to increase the size of the balloon to 13.5 mm resulted in perforation.The patient was treated conservatively using polyglycolic acid sheet with fibrin glue at the perforation site, which was fixed using an endoclip.However, the esophageal stricture persisted after the perforation was closed and endoscopic balloon dilation was carefully repeated twice weekly up to a maximum of 17 mm, and the endoscope was able to pass through, and associated symptoms improved.This report indicates that endoscopic tissue shielding using polyglycolic acid sheet with fibrin glue and endoclip to correct perforation, followed by additional endoscopic balloon dilation, is an alternative to surgery.Since the literature described "ezdilate(8 mm)", we selected "bd-400p-0880" as a representative product.The product was unknown.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There is no evidence of an olympus device malfunction.The root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 6-7-8
• Common Device Name: OESOPHAGEAL BALLOON CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave n; brooklyn park MN 55445
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 14575398
• Report Number: 3011050570-2022-00069
• Device Sequence Number: 12290471
• Product Code: KNQ
• UDI-Device Identifier: 00821925033160
• UDI-Public: 00821925033160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT-KNQ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: BD-400P-0880
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 09/23/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male