MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4187-24
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
Event or Problem Description
It was reported one month following implant of a smiths medical deltec® port-a-cath® implantable venous access system the patient was noted to have extravasation of the chemotherapy.The patient had been receiving chemotherapy for hepatic biliary cancer.A chest x-ray was ordered and resulted that the device had possibly migrated into the right ventricle / atrium.Subsequently, due to the risk of embolization, it was required that the device be explanted in interventional radiology (ir).The patient recovered with no further adverse effects.

• Brand Name: DELTEC® PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6997733
• Report Number: 3012307300-2017-02356
• Device Sequence Number: 1181508
• Product Code: LJT
• UDI-Device Identifier: 10610586012839
• UDI-Public: 10610586012839
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2017

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: 01/01/2020
• Device Catalogue Number: 21-4187-24
• Device Lot Number: 2934754
• 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: 10/23/2017
• Initial Report FDA Received Date: 11/02/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 44 YR