MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / VORTEX; PORT & CATHETER, IMPLANTED

Catalog Number	H787PSAX10I0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the device was not returned for evaluation, x-rays were provided and the investigation into this event is on-going.Upon completion of the investigation a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, catheter split/broke in patient and was removed on (b)(6) 2017.Port had been placed on (b)(6) 2017 by dr.(b)(6).The initial x-ray after the port placement showed the catheter in one piece.No sample will be returned, however x-rays of the device prior to removal were provided.
Additional Manufacturer Narrative
A review of the device history records (dhr) was performed for the indicated 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.The august 2017 angiodynamics complaint report was reviewed for the vortex port (triumph) product family and the failure mode "catheter detached (from port)." no adverse trends were indicated.The used device was not returned to angiodynamics, however x-ray images were provided.Based on the x-rays supplied from the hospital, the complaint of "catheter detached from port" is deemed confirmed.A potential root cause for the catheter detaching from the port may be that responsible employees failed to properly assemble the device per angiodynamics' procedures, and did not identify the non-conforming unit during their inspections.(this device is supplied to the end user with the catheter already attached to the port.).The operator involved in performing the procedures, according to the dhr, is no longer employed by angiodynamics, however had been trained at the time of employment.The instructions for use provided with the device include instructions on port placement, usage, and potential complications.((b)(4)).

• Brand Name: ANGIODYNAMICS / VORTEX
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6858985
• Report Number: 1056436-2017-00102
• Device Sequence Number: 10886453
• Product Code: LJT
• UDI-Device Identifier: H787PSAX10I0
• UDI-Public: H787PSAX10I0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: H787PSAX10I0
• Device Lot Number: 5160302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 09/19/2017
• 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