MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (FW) 8.5-9.5-10.5

Model Number	BD-400P-1080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is not yet available for this event.Device will not be returned.As such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be submitted when any relevant new information is available.
Event or Problem Description
As reported for this event by the customer, during an unknown therapeutic procedure, the balloon was inflated and deflated prior to the balloon rupturing after inflation.All the balloon pieces were recovered.There is no reported harm to the patient.
Additional Manufacturer Narrative
The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records.This supplemental report is being submitted to provide this information.Physical evaluation of the device cannot be performed as the customer is not returning device.The device history record review was performed by the other equipment manufacturer (oem) for the finished device and found no abnormalities in documentation or process.Due to the limited information provided by the customer and no device return, a root cause cannot be determined.However, the oem has provided common causes for this failure.The balloon may have been creased or scored when it was being inserted or retrieved through the endoscope this might cause the balloon to puncture or rip when inflated.If the balloon was not deflated sufficiently before retrieval, too much force may have been applied to withdraw the catheter.This would put strain on the proximal joint and could cause leakage.In addition, all balloons are leak tested during manufacturing to ensure there is no leakage.Leaking balloons are rejected.
Additional Manufacturer Narrative
Additional information has been received for this event.This supplemental report is being submitted to provide this information.The device was inspected before use with no anomalies found.Patient details and demographics are unavailable.Event happened in the middle of the procedure.Name of the procedure is unknown.There was an unspecified delay.Procedure was completed with a device of same model number, lot number is not known.It is not known if the patient needed additional anesthesia.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 8.5-9.5-10.5
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12100430
• Report Number: 3003790304-2021-00122
• Device Sequence Number: 14444451
• Product Code: KNQ
• UDI-Device Identifier: 00821925033177
• UDI-Public: 00821925033177
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: BD-400P-1080
• Device Lot Number: 503059A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/23/2021; 08/03/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/29/2021; 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1