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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 06/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

International customer reported that a patient received a vital-port detached silicone catheter titanium infusion port on an unspecified date.The device was implanted in the patients right arm.The patient developed an "intolerance reaction with a visible swelling " at an unspecified time following implant of the device.The swelling is noted along the subcutaneous course of the catheter and at the port implant site.There is no report of infection.The vital-port detached silicone catheter titanium infusion port was explanted and replaced with an unspecified peripherally inserted central catheter (picc) line.No further event or patient information was provided.Other than the reported swelling in the arm, no other information was reported regarding the patient's condition.

Manufacturer Narrative

Investigation summary: the affect product was returned for evaluation and the event report was confirmed.The vital port was returned unassembled, along with the catheter lock and a length of catheter measuring approximately 45.5 cm.The visual inspection revealed there were no signs of holes or damage to the catheter when observed under magnification.The suture holes were not utilized.The instructions for use was reviewed which states under port suturing and site closure: "three sutures, with at least one at each end of the port, are recommended".A product evaluation was performed which showed the suture holes were not utilized during this case, and there was only one needle stick observed in the septum.Neither the port or the catheter were occluded.The customer supplied photos/images and there is evidence of redness of the implant area.The device history record was also reviewed for the lot number of the device, and no signs were found to indicate that a nonconforming product was released to the field.This device lot has not been previously reported on a complaint.A quality engineering risk assessment concluded that no risk reduction is necessary.

Event Description

There has been no additional information received regarding the event.

• 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 (Section G): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 4128458621
• MDR Report Key: 6684024
• MDR Text Key: 78957054
• Report Number: 2522007-2017-00026
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00827002264892
• UDI-Public: (01)00827002264892(17)190131(10)N134835
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

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: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Device Lot Number: N134835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2017
• Initial Date FDA Received: 07/03/2017
• Supplement Dates Manufacturer Received: 06/10/2017
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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): Required Intervention
• Patient Age: 40 YR