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

Catalog Number	21-4474-24
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter provided a catalog number of 21-4474-24, however, the reported lot of 87 x 006 corresponds with 21-4477-24.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that approximately three months after implantation, a port study showed a kink in a deltec® port-a-cath® ii implantable venous access system.The catheter was surgically removed and replaced with a new one.No permanent injury was reported.

• Brand Name: DELTEC® PORT-A-CATH® II IMPLANTABLE VENOUS ACCESS SYSTEM
• 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: 6736093
• Report Number: 3012307300-2017-01567
• Device Sequence Number: 13825494
• Product Code: LJT
• UDI-Device Identifier: 10610586039966
• UDI-Public: 10610586039966
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2017

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: Health Professional
• Device Expiration Date: 11/23/2021
• Device Catalogue Number: 21-4474-24
• Device Lot Number: 87X006
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/24/2017
• 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