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

Catalog Number 900-602-US

Device Problems Bent (1059); Fracture (1260)

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

Event Date 01/17/2017

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.(b)(4).Device not returned to date.

Event Description

As reported (b)(6) 2017: after the initial laparoscopic ablation, the physician withdrew the applicator in order to reinsert for an additional ablation.When withdrawing the applicator, it was noted the tip of the applicator had bent.It did not detach and remained fully intact.The physician used a 2nd catheter to complete the procedure without issue without any patient injury.It was reported the disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was one pmta accu2i intermediate applicator.A visual examination of the device noted that the tip of the applicator is bent.The site of the break/bend occurs where the tip meets the shaft of the device.Functional testing could not be conducted due to the condition of the returned sample.The customer's reported complaint description of the tip fracture is confirmed.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 definitive root cause for the reported complaint description cannot be determined.However, based on the device history review this event does not appear to be manufacturing related.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 ifu states; "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 INTERMEDIATE 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: 6325253
• MDR Text Key: 67221320
• Report Number: 1319211-2017-00014
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 900-602-US
• Device Lot Number: 15120359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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