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

Catalog Number	900-601-US
Medical Device Problem Codes	Detachment Of Device Component (1104); Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).Device not returned to date.
Event or Problem Description
As reported to angiodynamics on (b)(6) 2017: during an infusion procedure, it was note the marker band had slipped off the catheter and into the patient.The physician was able to successfully remove the maker band from the patient via a snare.There was no harm or injury to the patient due to this event.It was reported that the disposable device is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one pmta accu2i long applicator.A visual examination of the device noted that the tip of the applicator is fractured off.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.Complaint # (b)(4).
Event or Problem Description
Based on sample received by angiodynamics on june 13 2017: it was originally reported by the user on (b)(6) 2016 that there was a "fault with the applicator".A failure mode of "fault" would not be considered a reportable event.However, based on the sample evaluation performed on june 13 2017, it was noted the tip of the applicator had fractured off.This failure mode of "fracture" meets the criteria of reportability.There was no report of patient harm or injury due to this event.

• Brand Name: PMTA ACCU2I LONG APPLICATOR
• Common Device Name: MICROWAVE APPLICATOR
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6653296
• Report Number: 1319211-2017-00070
• Device Sequence Number: 1464941
• Product Code: NEY
• UDI-Device Identifier: H787124018025
• UDI-Public: H787124018025
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K122762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 900-601-US
• Device Lot Number: 16190537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention