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

Catalog Number	H787LVTX52130
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device sample from the reported event is in transit to angiodynamics, but has not yet been received or evaluated.Upon completion of the investigation a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by hospital in (b)(6), "during linogram saw that contrast was leaking out of one port chamber.The device had been implanted (b)(6) 2016." it was removed and replaced on (b)(6) 2018.No additional patient complications were reported.The used device is being returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number (b)(4).In order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The shr indicated the reporting customer only received {one lot} of this item number in the six months prior to the procedure.The {one} lot obtained through the shr was (5238632).The device history records for the lot obtained through the ship history report (packaging lot) was reviewed.In addition, the corresponding lot for purchased component (septum) item number (100241 sln 13955) and purchased catheter tubing item number {107478 sln 5154966} were reviewed.The device history records were reviewed 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 2018 angiodynamics complaint report was reviewed for the lifeport product family and the failure mode "device leaked." no adverse trend was identified.The port with catheter tubing attached was returned for evaluation.The port was pressurized with air and submerged in water.A leak was detected in the left septum near the edge of the septum.Microscopic examination showed damage to the septum from needle sticks in the area of the leak.The septum was removed and coring was noted in the septum.Two large holes were also noted in the septum.: the reported complaint description of leak is confirmed.Damage to the port septum was observed that is consistent with the use of an improper needle (coring).The directions for use packaged with the port states: "use of angiodynamics anti-coring (19 to 22 gauge huber point) needles in all procedures is recommended.These needles have been designed and tested to ensure that septum life is preserved." the root cause for this event is handling damage (user error) during use of the device with a coring needle.(pr19751).

• Brand Name: ANGIODYNAMICS / VORTEX PORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7634838
• Report Number: 1317056-2018-00121
• Device Sequence Number: 2512565
• Product Code: LJT
• UDI-Device Identifier: H787LVTX52130
• UDI-Public: H787LVTX52130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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 Catalogue Number: H787LVTX52130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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
• Patient Age: 13 YR