MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. DELTEC PORT-A-CATHII IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	21-4471-24
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a 7 cm leak occurred to a smiths medical deltec® port-a-cath®ii implantable access system.It was reported that the patient had been experiencing should pain.An x-ray was ordered and revealed a leak under the corresponding clavicle.The port was explanted and replaced.The physician reported that a hole is made next to the port enable to get the guidewire in for insertion.There were no further reported adverse patient effects.
Additional Manufacturer Narrative
Device evaluation: one used portal was returned with an attached catheter measuring 6 inches in length.Upon pressurization of less than 5 psi via water a leak was found in the catheter length.The leak is located approximately 3 inches from where it had been attached to the portal and is from a longitudinal slit measuring 3/8 inches in length.The physical characteristics of the slit and its location is consistent with having been exposed to first rib/clavicle compression syndrome as is described in the products ifu section ii warnings, 3rd bullet.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.Problem source was traced to user interface.
Additional Manufacturer Narrative
D4, h4,h6: additional information received upon receipt of device at manufacturer's investigation site.

• Brand Name: DELTEC PORT-A-CATHII IMPLANTABLE ACCESS SYSTEM
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9386749
• Report Number: 3012307300-2019-07103
• Device Sequence Number: 2219857
• Product Code: LJT
• UDI-Device Identifier: 10610586032745
• UDI-Public: 10610586032745
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2020

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: 08/01/2021
• Device Model Number: 21-4471-24
• Device Catalogue Number: 21-4471-24
• Device Lot Number: 3277926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 03/26/2020; 09/03/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 07/02/2020; 09/23/2020
• 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