MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (WG) 16-17-18

Model Number BD-410X-1855

Device Problems Deflation Problem (1149); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus (b)(4) and is being shipped to oem (original equipment manufacturer) for evaluation.This report will be supplemented accordingly following investigations.

Event Description

It was reported that the balloon burst/rupture during dilation procedure.The intended procedure was completed using similar device.The lot number used was not provided.There was no patient harm or injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation and the (sbc) service business center final investigation.The device was returned to the olympus, brooklyn park facility with the report that the balloon burst during a procedure.The device was returned inside the original packaging, the packaging was taped closed.The model number was confirmed to be bd-410x-1855.The lot number is 508060f.The device was removed from the packaging and inspected.The balloon was inspected and the balloon was completely torn off the device.Only some small remains of the balloon are still attached.The inner wire of the balloon does not appear to be damaged.The guidewire was inserted into the proper luer and the guidewire was able to be moved through the device smoothly as intended.The catheter was inspected and there was no sign of kinks or damages on the catheter.The balloon was unable to be function tested and inspected as the balloon is no longer on the device and was not returned for inspection.Based on the results of the investigation, a definitive root cause could not be established.An evaluation of the device could not confirm the suggested phenomenon.No cause could be assumed from the information provided for this investigation.Fu (instruction for use) states as follows: warning: never use air or another gas product to inflate the ezdilate wire guided balloon.Caution: it is strongly recommended that an inflation device with a pressure gauge designed to deliver/monitor pressures exceeding the rated burst pressure for the balloon is used, so that inflation pressure can be accurately monitored.Inadequate pressure monitoring may result in over-inflation of the balloon and an increase in the risk of patient injury.The ezdilate wire guided balloon can only be inflated with fluid (sterile saline, sterile water or a mixture of contrast medium and sterile saline or sterile water)." warning: 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 monitor complaints for this device.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 16-17-18
• Type of Device: EZDILATE BALLOON DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 11920257
• MDR Text Key: 257449584
• Report Number: 3003790304-2021-00100
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00821925033269
• UDI-Public: 00821925033269
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K143609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-410X-1855
• Device Lot Number: 508060F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1