MAUDE Adverse Event Report: ANGIODYNAMICS PMTA ACCU2I LONG APPLICATOR; MICROWAVE APPLICATOR

Catalog Number 900-601-US

Device Problems Bent (1059); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported to angiodynamics on (b)(6) 2017: during a microwave ablation procedure of the liver, after the applicator had been placed, it was noted the tip of the applicator had bent.The tip remained fully attached to the applicator shaft.The device was removed and the procedure was completed with a new of the same device.The reported disposable device has been returned to the manufacturer for evalaution.

Manufacturer Narrative

Returned for evaluation was one pmta accu2i long applicator.A visual examination of the device noted that the tip of the applicator is bent.The site of the break/ bend occurs where the tip meets the shaft of the device.This tip did not fully detach from the shaft.Functional testing could not be performed due to the condition of the returned device.The customer's reported complaint description of the tip of the applicator being bent (fractured) is confirmed.Although the complaint description is confirmed, a definitive root cause for the event cannot be determined.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Based on the device history review this event does not appear to be due to a manufacturing defect.The most likely root cause to this event is due to operational context; i.E.Probe placement into hard tissue or lateral forces on the applicator tip during placement or removal.The complaint description states that the tip bent when in the liver, with lateral force.The instructions for use, which is supplied to with catalog number, contains a statement "always advance the applicator into the target tissue using axial forces only.Avoid placing lateral forces on the applicator tip during placement or removal" and lateral forces on the applicator tip should be avoided both during insertion and removal.Failure to do so could result in damage to the microwave array, failure of the applicator and injury to the patient." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: PMTA ACCU2I LONG APPLICATOR
• Type of Device: MICROWAVE APPLICATOR
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6507990
• MDR Text Key: 73286414
• Report Number: 1319211-2017-00047
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 900-601-US
• Device Lot Number: 16420607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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