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 Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

The device has been received for evaluation and the investigation is ongoing.Final results are forthcoming.(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

The international customer reported a separation between the catheter and vital port portions of the vital-port detached silicone catheter titanium infusion port device.The catheter was subsequently removed from the patient's body using a snare.The vital port was also removed from the patient's body.It was confirmed during the removal of the vital port that the locking sleeve was attached to the vital port, but there were no signs of rupture on the removed catheter.No additional venous port systems have been used in the patient for the time being.The product problem and subsequent intervention reportedly occurred on (b)(6) 2017, and the device was first implanted on (b)(6) 2017.The device has been returned for evaluation, and the investigation is ongoing.

Manufacturer Narrative

Summary of investigation: investigation summary: the complaint device was returned for an investigation.The catheter, port housing and catheter lock were retuned.The lock was not attached to the port outlet and the catheter was returned in one piece.There was slight evidence of bruising on the catheter.There was no evidence of calcification or damage on the catheter surfaces.There were puncture marks evident in the septum, two of the suture holes were utilized and one needle mark was evident on the port housing.There were no occlusions in the port or in the catheter when flushed.The instructions for use were reviewed which indicates three sutures are to be used on the port with at least one at each end of the port.The instructions for use also includes instructions and figures for placement in the arm.The device history record was reviewed.There are no signs in the device history record to indicate that this vital port was shipped to the field nonconforming.The complaint was confirmed through customer testimony.The investigation results concluded that the reported event root cause is due to operational or environmental context.Per the quality engineering risk assessment (qera), 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 ; 1186 montgomery lane; vandergrift, PA 15690 ; 4128458621
• MDR Report Key: 7143102
• MDR Text Key: 95655741
• Report Number: 2522007-2017-00048
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00827002465466
• UDI-Public: (01)00827002465466(17)200131(10)N143927
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S5116-N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention