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

Catalog Number 900-600

Device Problem Bent (1059)

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

Event Date 09/01/2014

Event Type  malfunction  

Event Description

As reported (b)(6) 2015, patient of unknown age and gender presented for an microwave procedure.During the procedure, when the treating physician noted the tip of the applicator probe appeared to be bent.The device was set aside and the procedure was successfully completed using a new of the same device.There was no report of patient harm or injury due to this event.It was reported the disposable device is available for return the manufacturer.

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 any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Complaint # (b)(4).

Manufacturer Narrative

Returned for evaluation was one used pmta accu2i standard applicator.Visual examination noted tip of the applicator was, bent approx.30 degrees.However the tip of the applicator was attached to the needle.Functional testing could not be conducted due to the condition of the returned sample.The customer's reported complaint description of the tip being bent is confirmed.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 operational context; i.E.Probe placement into hard tissue or lateral forces on the applicator tip during placement or removal.A review of the device history records was performed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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.(b)(4).

• Brand Name: PMTA ACCU2I STANDARD APPLICATOR
• Type of Device: MICROWAVE APPLICATOR
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4898672
• MDR Text Key: 6020011
• Report Number: 1319211-2015-00298
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K122762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 900-600
• Device Lot Number: 13500229
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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