MAUDE Adverse Event Report: VENTION MEDICAL DESIGN AND DEVELOPMENT, INC. EZDILATE BALLOON DILATOR (FW) 18-19-20

Model Number BD-400P-2080

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported device issue could not be conclusively determined at this time; however, user handling and the operator¿s technique could not be ruled out as a contributory factor to the reported event.The instruction manual warns users, ¿when inflating, do not exceed maximum pressure identified on the balloon inflation guide (also on the package label and pouch label).Over-inflation of the balloon may cause a rupture and could result in patient injury.If the balloon loses pressure during inflation or bursts, carefully remove the balloon and endoscope together.Do not attempt to remove a burst or leaking balloon through the endoscope.¿ olympus will continue to investigate this report and if additional information becomes available or if the device is returned at a later time, this report will be supplemented accordingly.

Event Description

Olympus was informed that during an unspecified procedure, the balloon device popped and shredded inside the patient.The user facility believed there are no pieces left behind inside the patient.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to report additional information received from the user facility.Olympus received additional information that states the patient underwent a diagnostic esophagogastroduodenoscopy (egd) with dilation procedure.There was only minor bleeding observed.The user facility reported this is the normal amount of bleeding when dilation is preformed.The balloon popped and deflated 30 seconds into full inflation at 20mm.There were no fragments as the balloon remained intact and split towards the proximal end of the balloon.The user facility reported that the patient was inspected for abrasions and missing tissue, however, no anomalies were found.The patient presented to the facility the next day for a routine follow up without issue.Additionally, it was reported that the balloon and balloon dilator were inspected prior to use and no anomalies were noted.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results and report additional information received from the original equipment manufacturer (oem).The oem performed a review of the device subassembly and device history record (dhr) and there were no anomalies noted during the documentation or manufacturing process.The bd-400p-2080 balloon dilator was returned for evaluation.A visual inspection was performed on the returned device and found a guidewire attached between the proximal bond and distal bond.The evaluation also noted ragged balloon edges attached in the bonded areas of the device.There were no visual defects noted to the balloon dilator.The oem reports that due to the partial balloon return, the exact cause of the reported event could not determined.However, it is possible that the customer's inflation device is incorrectly calibrated causing the balloon to be over inflated.The specified pressure for maximum dilation (20mm) is 5atm.The quality control limit release specification is a lower control limit (lcl) of 6atm.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Type of Device: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Manufacturer (Section D): VENTION MEDICAL DESIGN AND DEVELOPMENT, INC.; 261 cedar hill street; marlborough MA 01752
• MDR Report Key: 7374325
• MDR Text Key: 103944638
• Report Number: 2951238-2018-00216
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-2080
• Device Catalogue Number: BD-400P-2080
• Device Lot Number: 513107D
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS EGD SCOPE HQ-190/SN: (B)(4)
• Patient Age: 46 YR
• Patient Weight: 101