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

Catalog Number 900-600

Device Problems Bent (1059); Fracture (1260)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported november 21, 2016, a patient of unknown age and gender presented for a microwave procedure of the lung.During preparation for the procedure, when opening the sterile packaging, it was noted the tip of the applicator probe was bent, but remained fully attached to the applicator shaft.The device was set aside and a new of the same was used to successfully complete the procedure.There was no harm or injury to the patient due to this event as the device did not come into contact with the patient.It was reported the disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was one pmta accu2i standard applicator.A visual examination of the device noted that the tip of the applicator was broken.There was no evidence of damage to the shelf box.Functional testing could not be performed due to the condition of the returned device.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.Although the complaint description is confirmed, a definitive root cause for the tip fracture cannot be determined.As there was no damage to the self-box, it is possible that the tip was bent when attempting to remove device from the tray.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 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.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.Complaint # (b)(4).

• Brand Name: PMTA ACCU2I STANDARD APPLICATOR
• Type of Device: MICROWAVE APPLICATOR
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6178737
• MDR Text Key: 62534443
• Report Number: 1319211-2016-00168
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 900-600
• Device Lot Number: 16010489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• 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