MAUDE Adverse Event Report: ANGIODYNAMICS, INC. 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 08/26/2016

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 (b)(6) 2016, a patient of unknown age and gender presented for a microwave procedure.During preparation for the procedure, when the sterile packaging was opened, it was noted the tip of the applicator probe was bent.The device was set aside and a new of the same device was used to successfully complete the procedure.There was no patient impact as the device did not come into contact with the patient.The reported disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was one pmta accu2i long applicator.A visual examination of the device noted that the tip of the applicator was broken.The site of the break appears clean and occurs where the tip meets the shaft of the device.The internal ptfe insulation appears to be bent and drawn out, leaving a "tail" from the end of the shaft at the site of the fracture.This indicates the tip was bent, triggering the fracture.Functional testing could not be conducted due to the condition of the returned sample.The customer's reported complaint description of the tip fracture is confirmed.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.A possible contributing factor could have been operational context; i.E.Probe placement into hard tissue or lateral forces on the applicator tip during placement or removal.The ifu states; "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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: PMTA ACCU2I LONG APPLICATOR
• Type of Device: MICROWAVE APPLICATOR
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 5966051
• MDR Text Key: 55223935
• Report Number: 1319211-2016-00132
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 900-601-US
• Device Lot Number: 16150526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• 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