MAUDE Adverse Event Report: COOK VASCULAR INC. VITAL-PORT ATTACHED SILICONE CATHETER PLASTIC INFUSION PORT; SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number IP-6018

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104); Foreign Body In Patient (2687)

Event Date 11/29/2013

Event Type  Injury  

Event Description

Description according to complainant, "lower chest was incised to free up portacath for removal."on pulling it was noted that it was very stuck in the neck was opened." the internal jugular vein was explored and the portacath was freed and removed.We then attempted to remove the portacath from the subcutaneous track but it was stuck.A third incision was made to free this up." no part of the device remained inside the pt, however, two extra incisions were required to remove this implant.Pt has an increased risk to infection with 2 extra wounds, increased anaesthetic of 1.5 hours to do the procedure.

Manufacturer Narrative

(b)(4).One length of used catheter tubing (approx 18.5 cm) was returned with this complaint.It was noted that the end of the catheter was cut at an angle.Visual inspection confirmed the report of calcification on the outer diameter of the catheter.The catheter retained flexibility and no puncture marks were observed on the catheter.The catheter was observed under magnification and no burnishing or wear was present.A dimensional analysis confirmed that the catheter was manufactured to cvi specs.The calcification of the catheter was confirmed.The lack of burnishing confirms the customer report that the catheter was cut for removal from the body, i.E.The catheter did not fracture during treatment.There is no indication device performance was affected.The catheter was manufactured to cvi specs.The ifu contains a notice that the formation of calcium-like deposits is a known complication of the implantation of a catheter.The root cause of the deposit is unk.None required per given rpn.

• Brand Name: VITAL-PORT ATTACHED SILICONE CATHETER PLASTIC INFUSION PORT
• Type of Device: SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): COOK VASCULAR INC.; vandergrift PA 15690
• Manufacturer Contact: brian johnston, mgr ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 3591093
• MDR Text Key: 16011035
• Report Number: 2522007-2013-00042
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K951076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: IP-6018
• Device Catalogue Number: IP-6018
• Device Lot Number: N88443
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/27/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 11 YR
• Patient Weight: 52