MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX MP VASCULAR ACCESS PORT; VORTEX¿ MP VASCULAR ACCESS PORT

Catalog Number	H787P12105K0
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was one vortex port.As received, the port was returned with bio material {blood} inside and out.The catheter tubing was fractured at the connection site.There was an amber colored precipitate observed on the top of the sleeve where catheter/sleeve connect to the port outlet tube.Precipitate was also located at the fractured end of the catheter tubing/sleeve (distal end of outlet tube).Upon cleaning the precipitate from the device there was damage observed on the top and bottom of the catheter/sleeve.This damage was likely caused by serrated hemostat clamps and is the likely root cause for the catheter fracture.The distal tip of the catheter tubing had a clean cut at the end with a slight angle to the cut.Catheter tubing was trimmed to just over the 12 cm mark.The device met all dimensional specifications.The customer's reported complaint description of port catheter tubing fracture and migrated is confirmed.The port device was returned with a small portion of the catheter tubing and sleeve attached to the port connector pin (outlet tube).In addition, the remaining portion of the catheter tubing was returned, i.E.Rest of sleeve and distal catheter tubing.Damage was observed to the top and bottom of the sleeve and catheter tubing at the connection to the port outlet tube.This type of damage is indicative of hemostat clamps.The sleeve, catheter tubing and port connector pin (outlet tube) were measured and confirmed to meet device dimensional specifications.No manufacturing non-conformances were observed during sample evaluation.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 likely root cause of this catheter fracture event is damage to the sleeve/catheter tubing from hemostat clamps during the port placement procedure.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint reference (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2016: (b)(6) 2015: vortex port was implanted in patient.The port body was placed on right side of chest and catheter tunneled up to insertion point of catheter in subclavian vein.(b)(6) 2016: hospital staff was unable to flush the port.Chest x-ray on the patient on the same day revealed separation of the catheter from the port body.The catheter was completely severed from the port at the point where the exit stem of the port body ends.(b)(6) 2016: port and catheter were explanted.Delay of explant was due to the patient being unwell.The patient was then implanted with another vortex port.The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

• Brand Name: VORTEX MP VASCULAR ACCESS PORT
• Common Device Name: VORTEX¿ MP VASCULAR ACCESS PORT
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6701839
• Report Number: 1056436-2017-00046
• Device Sequence Number: 13673366
• Product Code: LJT
• UDI-Device Identifier: H787P12105K0
• UDI-Public: H787P12105K0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: H787P12105K0
• Device Lot Number: 4739368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 MO