MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX CT PORT ACCESS SYSTEM; SMARTPORT CT

Catalog Number	H787CT80STPAVI1
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference (b)(4).Device unavailable for return.
Event or Problem Description
As reported to angiodynamics on march 22, 2017: when flushing the port, the patient reported experiencing slight pain.It was noted the port catheter had fractured.It was reported the defective device was removed.The patient did not suffer any adverse effect due to this event.It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
This complaint file (b)(4) has been canceled in angiodynamics' complaint system.The sales rep had estimated that the reporting account had 8 events, however, upon further investigation, there were only 6 events.Therefore, this complaint is not required.This supplemental medwatch is being filed in order to report this change in status.Complaint reference (b)(4).

• Brand Name: VORTEX CT PORT ACCESS SYSTEM
• Common Device Name: SMARTPORT CT
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6508022
• Report Number: 1056436-2017-00076
• Device Sequence Number: 1344828
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPAVI1
• UDI-Public: H787CT80STPAVI1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician Assistant
• Device Catalogue Number: H787CT80STPAVI1
• 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: 03/22/2017
• Supplement Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1