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

Catalog Number 900-600

Device Problems Bent (1059); Device Issue (2379)

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

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported (b)(6) 2017: during the procedure the applicator was removed for reinsertion.At the time of the second insertion the ceramic tip bent inside the patient's kidney.The tip did not detach from the applicator shaft and remained fully attached.The device was set aside and the procedure was completed with a new of the same device.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 the tubing was cut and the tip was bent but still fully attached.The site of the bend occurs where the tip meets the shaft of the device.The thermocouple wires are still intact within the tip.Functional testing could not be performed due to the condition of the returned device.The customer's reported complaint description of the tip of the applicator being bent is confirmed.Although the complaint description is confirmed, a definitive root cause for the event cannot be determined.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.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 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, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6332332
• MDR Text Key: 67494064
• Report Number: 1319211-2017-00024
• 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: distributor,foreign,health pr
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 900-600
• Device Lot Number: 16120512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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
• Patient Outcome(s): Required Intervention