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 Codes	Migration or Expulsion of Device (1395); Material Separation (1562)
Health Effect - Clinical Codes	Stroke/CVA (1770); Embolism (1829); Atrial Perforation (2511)
Date of Event	09/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Phone number: (b)(6).Postal code: (b)(6).(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a (b)(6) female patient had complications from a vital port vascular access system placed on (b)(6) 2016 in the peripheral vein.The patient returned to the hospital on (b)(6) 2016 due to a catheter that sheared, resulting in an embolization of the distal part causing a cerebral stroke.It was noted the broken miniport catheter had about a 15cm connected to the chamber and the rest had migrated towards the heart from the superior vena cava into the right atrium.A perforation of unclear origin was noted and migration into the left atrium, with the tip headed to the left ventricle where it got stuck in the aortic valve.The physician reportedly determined the cerebral stroke was caused by thrombus originating from the migrated catheter tip in the aortic valve and that the thrombus traveled up to the head/brain area.The catheter and catheter tip were retrieved by the radiology department, the vital port was explanted and the cerebral thrombus was resolved.The patient is reported to have "recovered quite well from the cerebral stroke." the patient did require additional procedures due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation results - one used vital port was received with this complaint.The catheter lock and two lengths of catheter, approximately 10 cm and 46.5 cm in length, were returned.The 10 cm length of catheter was attached to the vital port housing along with the catheter lock.The catheter and catheter lock were attached per design.According to the customer complaint, ¿a catheter shear of a vital port vascular access system which was inserted to the peripheral vein.The catheter shear was followed by an embolization of the distal part causing a cerebral stroke.The location of implantation was inserted to peripheral vein in forearm.¿ visual inspection by the quality assurance and engineering departments confirmed that the complaint and that the catheter had fractured into two fragments.Visual inspection of the site of the fractures confirmed the presence of burnishing.Burnishing was observed on both catheter fragments.There was a slight yellow discoloration (approximately 9 cm) and a small area with a blue (<1cm) material on the catheter, no other holes, nicks, or abrasions were observed on the catheter.Inspection using a microscope found that the suture holes were not utilized on this port.No signs of damage or nonconformity was observed on the vital port body, outlet tube, or the catheter lock.A dimensional verification was performed on the catheter and the outlet tube.The instructions for use indicate that to avoid catheter damage the device it is to be implanted peripherally in the upper arm, positioning the catheter so that it enters the venous system in the lower third of the upper arm and below the vein passage through the deep brachial fascia.A potential adverse event/potential risk listed in the instructions for use mentions device fracture and fragmentation, among other risks.The instructions for use also instruct the user to anchor the port and warns that failure to adequately anchor the port increases the risk of catheter fracture and/or disconnection which may result in catheter migration.A dimensional verification, a functional test, and a visual inspection were conducted as well as a review of complaint history, device record history, documentation, instructions for use, manufacturing instructions and quality control procedures to assist in the investigation of the alleged product failure.Manufacturing records were reviewed and no signs were found to indicate that nonconforming product was released to the field.No other complaints have been filed for this device lot.There are no indications that the catheter or port body were manufactured outside of specification, or with an unapproved material.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
• 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: 6016314
• Report Number: 2522007-2016-00006
• Device Sequence Number: 1917560
• Product Code: DWF
• UDI-Device Identifier: 00827002264892
• UDI-Public: (01)00827002264892(17)170930(10)N123756
• Combination Product (Y/N): N
• PMA/510(K) Number: K931586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2016

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 Model Number: N/A
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 01/10/2017
• 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: Life Threatening
• Patient Age: 38 YR