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

Catalog Number	21-4025-24
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that the catheter of a deltec® port-a-cath® implantable venous access system separated from the port.The port and the catheter were surgically removed.No permanent injury was reported.
Event or Problem Description
The catheter removal was performed via interventional radiology.The event was considered resolved.
Additional Manufacturer Narrative
One used portal was received for evaluation.Visual inspection, using microscopy, was performed and revealed that one end of the catheter had the presence of many small longitudinal slits.Further inspection of the opposite end of the catheter revealed that the end was tipped.This tipped condition was found to be consistent with the distal end being used during patient placement.The reported complaint was confirmed based on visual inspection; however, because the remaining length of the catheter was not available for evaluation, this investigation could not establish a definitive root cause to the reported issue.While no definitive root cause could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: DELTEC® PORT-A-CATH® 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: 6751803
• Report Number: 3012307300-2017-01606
• Device Sequence Number: 18887091
• Product Code: LJT
• UDI-Device Identifier: 10610586023804
• UDI-Public: 10610586023804
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K830730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2017

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: No Information
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: 21-4025-24
• Device Lot Number: 2354961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 08/02/2017; 09/28/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 08/22/2017; 10/13/2017
• 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
• Patient Age: 38 YR
• Patient Weight: 64