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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	06/10/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
There has been no additional information received regarding the event.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Common Device Name: DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COOK VASCULAR INC.; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6684024
• Report Number: 2522007-2017-00026
• Device Sequence Number: 1971374
• Product Code: DWF
• UDI-Device Identifier: 00827002264892
• UDI-Public: (01)00827002264892(17)190131(10)N134835
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K931586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/10/2017
• Supplement Date Received by Manufacturer: 06/10/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR