MAUDE Adverse Event Report: COOK VASCULAR INC. VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT; NONE

Catalog Number IP-5116-N

Device Problems Break (1069); Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 06/24/2014

Event Type  Injury  

Event Description

On the (b)(6) 2011, the device was implanted in the right upper arm to conduct chemoradiation therapy for esophageal cancer.The chemoradiation therapy was continued until (b)(6) 2011.On (b)(6) 2013, esophageal cancer recurrence was confirmed with endoscopic examination.On the (b)(6) 2013, chest x-ray was conducted and no abnormality of the catheter was confirmed at that time.On the (b)(6) 2014 at 14:00 p.M., when the physician was going to use the implanted port in the upper arm for rehydration before angiography, blood return did not occur.Also, the pt complained about pain during flushing.On (b)(6) 2014 during a follow-up check, it was found that the catheter was broken at 3cm from the tip and the separated catheter was floating.Since the physician judged it was not an urgent case although the separated segment tip was placed in the right atrium (whether partially or completely placed it unk), he planned to remove the device on (b)(6) 2014.On (b)(6) 2014, the catheter was removed along with another med device.Also, the port was removed from the right upper arm.The pt had a favourable outcome.

Manufacturer Narrative

(b)(4).One mini titanium vital port was received with a catheter lock and two segments of catheter (~2.5 cm & ~34.5 cm).The 2.5 cm catheter segment was attached to the port body along with the catheter lock.The catheter was connected in accordance with ifu guidelines.A dimensional verification was performed on the inner and outer diameter of the catheter tubing, the outer diameter of the port body's outlet tube, and the outer diameter of the bump on the outlet tube.All dimensions met the acceptance criteria of the relevant drawing.Visual inspection confirmed that the suture holes were used.A visual inspection of the catheter tubing was performed under magnification.Burnishing was observation on approximately one third of the circumference of the catheter fragment proximal to the port body.Burnishing was observed on the distal catheter segment, but the wear was not as evident.The burnishing on the catheter's surface is indicative of long-term wear on the catheter surface.Friction on the surface of the catheter over the 3 year duration of implantation likely wore through the catheter.There is no evidence of mfg nonconformity.According to the comments in trackwise, the device was implanted in the pt's upper arm, but the specific implantation location is unk.While there is no evidence linking implantation location with the complaint, the customer is encouraged to review the instruction for proper implantation locations in the ifu.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Type of Device: NONE
• Manufacturer (Section D): COOK VASCULAR INC.; vandergrift PA 15690
• Manufacturer Contact: brian johnston, reg affairs mgr ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 4028144
• MDR Text Key: 16558079
• Report Number: 2522007-2014-00012
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2014

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 Catalogue Number: IP-5116-N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 67