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 03/17/2015

Event Type  malfunction  

Event Description

As reported (b)(4) 2015, pt of unk age and gender presented for a 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 the events.It was reported the disposable device is not available for return tho the mfr was it was disposed of by the user.Angiodynamics is attempting to obtain further details regarding the events 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 spec.(b)(4).

Manufacturer Narrative

Returned for evaluation was one used pmta applicator.Visual examination noted that the tip of the applicator was bent less than 10 degrees.Applicator passed functional testing.The reported complaint description of the tip being bent is confirmed.A definitive root cause for the reported complaint description cannot be determined.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 lot history records was performed for the reported applicator lot any deviation in manufacturing process related to the reported defect of the complaint.The review confirmed that the lot and the associated components used within the lot all conformed to manufacturing processes and testing.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.

• 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: 4766169
• MDR Text Key: 5950933
• Report Number: 1319211-2015-00263
• 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 Expiration Date: 09/30/2015
• Device Catalogue Number: 900-602
• Device Lot Number: 14400310
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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