MAUDE Adverse Event Report: ANGIODYNAMICS, INC SMART PORT CT; PORT AND CATHETER

Catalog Number CT80STPD

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

An (b)(6) year old male with esophageal cancer underwent mediport placement for chemo administration.Wire from mediport set was advanced into the ivc through a peel away sheath.Peel away introducer was not able to be locked and the inner dilator slid out.The peel away sheath was removed and placed in a biohazard bag for analysis following completion of procedure.

• Brand Name: SMART PORT CT
• Type of Device: PORT AND CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 26 forest st.; marlborough MA 01752
• MDR Report Key: 4557017
• MDR Text Key: 5548083
• Report Number: 4557017
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CT80STPD
• Device Lot Number: 4790183
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2015
• Patient Sequence Number: 1
• Patient Age: 83 YR