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

Catalog Number	H787CT66LTPD0
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the port from the reported event will not be returned to angiodynamics, the investigation into this event is ongoing including the gathering of additional information from the complaint reporter (the patient).A supplemental medwatch will be submitted at the conclusion of the investigation.((b)(4)).
Event or Problem Description
As reported by patient: a smart port was placed in 2013.It was removed on (b)(6) 2019 at community medical center in (b)(6).Per patient description, " dr.(b)(6) was trying to remove the port and was pressing so hard it fractured inside and a piece is left inside." the physician indicated that it would be acceptable to leave the piece in place.".
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 smart port product family and the failure mode, "catheter unretrieved device fragment." no adverse trend was identified.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The incoming inspection for tensile test on the catheter turbing were reviewed and met specification, with the incoming records complete and in order.Patient anatomy and drugs used during treatment are potential root causes of this failure.The directions for use packaged with the smart port provide guidance on port placement, maintenance, and removal technique as well as cautions and potential complications.(b)(4).

• 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: 8540656
• Report Number: 1317056-2019-00056
• Device Sequence Number: 1744608
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: H787CT66LTPD0
• Device Lot Number: 597175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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