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

Catalog Number 900-602

Device Problems Bent (1059); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/04/2016

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.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.(b)(4).

Event Description

As reported (b)(4) 2016, a patient of unknown age and gender presented for a microwave procedure.During the procedure, the treating physician withdrew the probe for repositioning.When attempting to reinsert it into the patient, the tip of the applicator bent.There was no report of the tip detaching from the applicator shaft.The device was set side and the procedure was aborted as another of the same device was not available to complete the procedure.It was reported the patient suffered no harm or injury due to the event.It was reported the disposable device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was used pmta accu2i intermediate applicator.A visual examination noted that tip of the applicator was bent, but still attached to the needle.Functional testing could not be performed due to the condition of the returned device.The reported complaint description of the tip of the applicator bending 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.Although the exact root cause of the event is unable to be determined, it does not appear to be the result of a manufacturing failure.A possible contributing factor could have been handling damage; i.E.Lateral forces on the applicator tip.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 INTERMEDIATE 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: dan anderson ; 603 queensbury avenue; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5538849
• MDR Text Key: 41578864
• Report Number: 1319211-2016-00042
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K122762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 900-602
• Device Lot Number: 15220384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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