MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® PORT-A-CATH® II POWER P.A.C. POLYSULFONE/TITANIUM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4471-24
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that at the end of therapy the explanting doctor noticed holes in the catheter of this port.The port had to be explanted.No additional adverse patient effects were reported.

• Brand Name: DELTEC® PORT-A-CATH® II POWER P.A.C. POLYSULFONE/TITANIUM
• 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: 7110175
• Report Number: 3012307300-2017-02516
• Device Sequence Number: 13681103
• Product Code: LJT
• UDI-Device Identifier: 10610586032745
• UDI-Public: 10610586032745
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 21-4471-24
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/12/2017
• 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: Required Intervention