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

Catalog Number	H787CT75STSD0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 february 2019 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter fractured/migrated." no adverse trend was indicated.Due to the lack of information provided on the voluntary medwatch form, the end user was unable to be contacted for additional information regarding the event and sample availability.Therefore, the report of fractured port catheter tubing is unable to be confirmed and the potential root cause is unable to be determined.The directions for use packaged with the smart port provide guidance on implantation and potential complications, including "catheter fragmentation and catheter pinch-off." (b)(4).
Event or Problem Description
As reported on voluntary medwatch, mw5084130, "patient came in for an infusaport removal after use of 5 years.Snap heard/felt when removing catheter.The distal half of the catheter remained and required extended procedure to remove successfully." no follow-up into this event was possible due to lack of information provided - no hospital name was given and a search into angiodynamics' shipping history for the provided port/lot # showed that it had shipped to 20 different hospitals.

• Brand Name: ANGIODYNAMICS / SMART PORT
• Common Device Name: PORT & CATHETER IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8459899
• Report Number: 1317056-2019-00051
• Device Sequence Number: 3013292
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: H787CT75STSD0
• Combination Product (Y/N): N
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: Health Professional
• Device Expiration Date: 06/03/2016
• Device Catalogue Number: H787CT75STSD0
• Device Lot Number: 597076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/28/2019
• 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