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

Catalog Number	H787SSAX16I0
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records 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 recent angiodynamics complaint report was reviewed for the vortex port product family and the failure mode "catheter fractured/migrated." no adverse trend was indicated.The reported complaint description of "catheter split off in patient while port was being removed" is not confirmed, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for the reported event.The instructions for use which is supplied to the user with this catalog number, contains the following statements: "potential complications: catheter fragmentation and catheter pinch-off." the instructions also provide guidance on port placement, maintenance, and removal.((b)(4)).
Event or Problem Description
As reported, during removal of an implanted port at (b)(6) medical center the catheter fractured.The patient had to be transferred to another facility because no interventional radiologist was available at (b)(6) medical center.No patient injury was reported.The used device has been discarded at the hospital.

• Brand Name: ANGIODYNAMICS / VORTEX
• Common Device Name: PORT & CATHETER , IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7618692
• Report Number: 1317056-2018-00111
• Device Sequence Number: 19187852
• Product Code: LJT
• UDI-Device Identifier: H787SSAX16I0
• UDI-Public: H787SSAX16I0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032557
• 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
• Report Date (Section B): 06/20/2018

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: 04/28/2020
• Device Catalogue Number: H787SSAX16I0
• Device Lot Number: 5158996
• 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: 05/23/2018
• Initial Report FDA Received Date: 06/20/2018
• 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