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

Catalog Number 900-600-US

Device Problems Bent (1059); Detachment Of Device Component (1104)

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

Event Date 11/20/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).Device unavailable for return.

Event Description

As reported to angiodynamics on (b)(6) 2017: when the treating physician withdrew the applicator from the patient during a microwave ablation procedure, it was noted the ceramic tip of the applicator had partially detached from the applicator shaft.The tip remain partially attached to the shaft by the internal wiring.It was reported the disposable device is not available for return to the manufacturer as it was disposed of by the user.

Manufacturer Narrative

Returned for evaluation was one pmta accu2i standard applicator.A visual examination of the device noted that the tip of the applicator is bent.There is also a slight bend in the shaft of the device.Functional testing could not be performed due to the condition of the returned device.The customer's reported complaint description of the tip fracture 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 handling damage; i.E.Lateral forces on the applicator tip.It is possible that the patient moving during the procedure while the applicator was in place could have contributed to the reported issue.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.(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 ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6384293
• MDR Text Key: 69271980
• Report Number: 1319211-2017-00028
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K122762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/30/2016
• Device Catalogue Number: 900-600-US
• Device Lot Number: 16320573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2014
• 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