MAUDE Adverse Event Report: ANGIODYNAMICS ALATUS; ALATUS PLUS VAGINAL BALLOON PACKING SYSTEM KIT

Catalog Number VBP-40

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

The reported device has yet to be returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A territory manager was informed from an end user of an issue with an adaptive radiology balloon.It was reported the customer had a leaking balloon.The physician and nurse noticed it was leaking after the procedure was completed.The procedure had been completed with this device and there was no report of the patient experiencing any adverse effects, harm, or require medical intervention as a result of this incident.As the balloon was reported as leaking during/after procedure, there was a risk of radiation to unintended organs, therefore this event meets the criteria for an adverse event.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

Manufacturer Narrative

This event was reassessed as not meeting the criteria of a reportable event based on additional information.This report is being submitted to close out the complaint file.Reference (b)(4).

Event Description

The event was inadvertently assessed as meeting reportability and after clarification with the complainant, it was determined that the balloon did not leak during patient treatment and therefore this event does not meet reportability.

• Brand Name: ALATUS
• Type of Device: ALATUS PLUS VAGINAL BALLOON PACKING SYSTEM KIT
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 12688737
• MDR Text Key: 278119029
• Report Number: 1319211-2021-00075
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K092534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: VBP-40
• Device Lot Number: 126998
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1