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

Catalog Number 900-602

Device Problems Bent (1059); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

As reported (b)(6) 2015, an (b)(6), male patient presented for an microwave procedure of the liver.During the procedure, when the treating physician withdrew the applicator to reposition, the physician noted the tip of the applicator probe appeared to be bent and partially detached.The device was set aside and the procedure was aborted.There was no report of patient harm or injury due to this event.It was reported the disposable device is available for return the manufacturer.

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 any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.

Manufacturer Narrative

Returned for evaluation was one used pmta accu2i standard applicator.A visual examination noted that the tip of the applicator was bent at a 45 degree angle.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 becoming damaged is confirmed.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 handling damage; i.E.Lateral forces on the applicator tip.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.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: 4890615
• MDR Text Key: 6834175
• Report Number: 1319211-2015-00299
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 900-602
• Device Lot Number: 15080351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Age: 80 YR