MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT; DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Inflammation (1932)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported that after implantation of a catheter port, leakage was noted along with, ¿little holes on proximal end of part catheter.¿ the patient required an additional procedure to have another port implanted which has reportedly resulted in inflammation.No additional information was available at the time of this report.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, dimensional verification, documentation, device history record, documentation, instructions for use (ifu), specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.The returned port along with a catheter lock and a length of catheter was measured to be approximately 55.6 cm from the port housing base to the catheter end.The device was assembled when it was received, however, the catheter lock was not assembled correctly.The catheter lock was placed on the catheter backward.When flushed during decontamination, signs of a leak from the body of the catheter was observed.Under magnification, a small hole could be seen.Small gouges were also observed on the face of the port housing.There were puncture marks present in the port septum, and one of the suture holes appeared to be used.The surface of the catheter was smooth, showing no signs of calcification or burnishing.A second functional test was performed in which the small hole in the catheter was blocked; which verified that there were no occlusions in the catheter or the port housing.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which; could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, operational context caused or contributed to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Type of Device: DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6157561
• MDR Text Key: 61863382
• Report Number: 2522007-2016-00012
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR