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

Catalog Number 900-602

Device Problem Bent (1059)

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

Event Date 09/01/2015

Event Type  malfunction  

Event Description

As reported (b)(4) 2015, pt of unk 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.There was no report of pt harm or injury due to this event.It was reported the disposable device is not available for return tho the mfr as it was disposed of by the user.Angiodynamics is attempting the obtain further details regarding the event and any further medical intervention taken by the treating physician.

Manufacturer Narrative

It was reported that the disposable device was discarded by the user and is not available to be returned to the mfr for eval.An investigation into the root cause of this incident is currently in progress.The results of the device eval will be sent via a f/u 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.(b)(4).

Manufacturer Narrative

As the reported complaint sample was disposed of by the user and not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of the tip bending could not be confirmed because the device was not returned for evaluation.Without receiving applicator for evaluation, we are unable to definitively determine a root cause for this incident.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 deviation 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.Complaint # (b)(4).

• Brand Name: PMTA ACCU2I INTERMEDIATE 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: 4766151
• MDR Text Key: 5777239
• Report Number: 1319211-2015-00258
• 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: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900-602
• Device Lot Number: 13480225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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