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

Catalog Number	H787MPP5SDT0
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/29/2017
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 (b)(6) 2017 angiodynamics complaint report was reviewed for the vortex port product family and the failure mode " difficult removal." no adverse trend was indicated.The customer's reported complaint description of "difficult to remove catheter " is not confirmed, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Patient anatomy and drugs used during treatment are potential root causes of this failure.The directions for use provided with the device contain guidance on port placement and maintenance.Potential complications such as catheter fragmentation and catheter pinch-off are reviewed.(b)(4).
Event or Problem Description
As reported: "port removed from left anterior chest.Catheter was secured with hemostat and catheter adjacent to the port broke with very little manipulation.Remainder of cath was mobilized and subq tissues showed obvious signs of abnormal tissue ingrowth and structural breakdown of the catheter wall.The placement incision was opened.And the remainder of the catheter in the subq tract was removed.As surgeon delicately mobilized the catheter in the soft tissue traveling under the clavicle toward the intravenous portion, the catheter broke and the remaining intravenous portion was unable to be removed.The tract was sewn over with 3-0 vicryl for hemostasis and the incisions were closed in 2 layers.The intravenous portion of the catheter remained in place.".

• Brand Name: ANGIODYNAMICS / VORTEX
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 7248868
• Report Number: 1056436-2018-00006
• Device Sequence Number: 16433598
• Product Code: LJT
• UDI-Device Identifier: H787MPP5SDT0
• UDI-Public: H787MPP5SDT0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K033473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: 03/31/2017
• Device Catalogue Number: H787MPP5SDT0
• Device Lot Number: 4739369
• 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: 01/16/2018
• Initial Report FDA Received Date: 02/07/2018
• 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: 6 YR
• Patient Weight: 21