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 Extravasation (1842)

Event Date 05/27/2015

Event Type  Injury  

Event Description

A female patient was undergoing chemotherapy, when the physician noticed an extravasation under the skin; which they thought could possibly be the port leaking.The surgeon explanted the port on (b)(6) 2015, and a new port device was implanted.A section of th device did not remain inside the patient's body.According to the initial report, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history and the device history record were conducted during the investigation.One used ip-s5116w-mpis-nt was returned along with a ~52cm length of catheter tubing.The catheter lock was not returned with this complaint.A visual inspection could not confirm the presence of holes or leakage on the port body or the catheter, though irregularities were observed at the edge of the septum.There was no evidence that the suture holes were used.A functional test was performed in which the catheter was attached to the port body and flushed with a non-coring syringe filled with water.No leakage was observed during this test.A second leak test was performed in which a dead-end was created through attaching a second port body at the end of the catheter.No leakage was initially observed.The pressure was increased until the catheter sprung a leak at the connection between the catheter and the second port body, i.E.Distal to the returned device.There is no evidence of leakage from the returned port body, and no evidence that the catheter was punctured prior to this test.A dimensional verification was performed on the catheter and the port body outlet tube.All dimensions were within specifications.Manufacturing records for this device were reviewed and no evidence of nonconformity was found.No other complaints have been filed for this manufacturing lot.There is no evidence to suggest the product was not manufactured to specification.The event resulted in harm that required medical intervention.While a leak was formed during a functional test, the leak was not present until the pressure was steadily increased.Because the complaint could not be replicated and no visual evidence of a leak was found prior to this destructive testing, the complaint cannot be confirmed.The root cause of the complaint is unknown.The customer is encouraged to review the instructions for use for proper catheter attachment technique.Per quality engineering risk assessment, no further risk reduction activities are necessary.

Event Description

A female patient was undergoing chemotherapy, when the physician noticed an extravasation under the skin; which they thought could possibly be the port leaking.The surgeon explanted the port on (b)(6) 2015 and a new port device was implanted.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4905454
• MDR Text Key: 6537065
• Report Number: 1820334-2015-00393
• 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: Foreign,User Facility,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

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 Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Device Lot Number: N120513
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/27/2015
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention