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

Catalog Number 900-601-US

Device Problems Bent (1059); Insufficient Information (3190)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 03/07/2016

Event Type  malfunction  

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 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.(b)(4).

Event Description

As reported (b)(6) 2016, a patient of unknown age and gender presented for a microwave procedure of the liver.During the procedure, the treating physician withdrew the probe for repositioning.When attempting to reinsert the applicator the physician used lateral force, at which time the applicator tip detached from the applicator shaft.The tip remained inside of the patient.In order to retrieve the tip, the treating physician changed the procedure to laparoscopic.It was reported the patient suffered no permanent harm or injury due to the event.It was reported the disposable device is available for return to the manufacturer for a device evaluation.

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 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.(b)(4).Update 3/31/16: the initial report 1319211-2016-00045 was esubmitted.The mdr failed as it was not "packaged." no acknowledgement receipts were received.The document was removed from the submissions, repackaged and resubmitted.The resubmission failed as it was "already submitted".Therefore, we are resubmitting as follow up #1.All information has been retained in the follow up.

Event Description

As reported (b)(6) 2016, a patient of unknown age and gender presented for a microwave procedure of the liver.During the procedure, the treating physician withdrew the probe for repositioning.When attempting to reinsert the applicator the physician used lateral force, at which time the applicator tip detached from the applicator shaft.The tip remained inside of the patient.In order to retrieve the tip, the treating physician changed the procedure to laparoscopic.It was reported the patient suffered no permanent harm or injury due to the event.It was reported the disposable device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was one pmta accu2i standard applicator.A visual examination of the device noted that the tip of the applicator was broken off/fully detached and was not received for evaluation.The shaft of the applicator is fractured as well.Functional testing could not be performed due to the condition of the returned device.The customer's reported complaint description of tip fracture is confirmed.Although the complaint description is confirmed, a definitive root cause for the event cannot be determined.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.Due to the condition of the returned device, a root cause cannot be determined although based of the devise history review this event does not appear to be due to a manufacturing defect.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 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 LONG 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: 5539089
• MDR Text Key: 41587487
• Report Number: 1319211-2016-00045
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 900-601-US
• Device Lot Number: 15480475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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