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

Catalog Number	H787CT96STSD0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
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.Complaint reference (b)(4).Device not returned to date.
Event or Problem Description
As reported to angiodynamics on february 09, 2017: port placed on (b)(6) 2016 for blood draws and chemotherapy.(b)(6) 2016, when receiving chemotherapy, the patient experienced pain, under imaging, it was noted the catheter had detached and migrated inside of the patient.It was reported the catheter had not migrated out of the right ventricle.The port and fractured catheter were removed.A new of the same device was implanted in a future procedure.It was reported the patient was stable post event.It was reported defective device is available for return to the manufacturer for a device evaluation.

• 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: 6381123
• Report Number: 1056436-2017-00025
• Device Sequence Number: 13621684
• Product Code: LJT
• UDI-Device Identifier: H787CT96STSD0
• UDI-Public: H787CT96STSD0
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

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
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: H787CT96STSD0
• Device Lot Number: 5087897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 03/06/2017
• 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
• Patient Age: 46 YR