MAUDE Adverse Event Report: COOK VASCULAR INC VITAL PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

Catalog Number IP-S5116W-MPIS-NT

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem Arrhythmia (1721)

Event Date 02/05/2015

Event Type  Injury  

Event Description

On (b)(6) 2014, a vital port was implanted on the patient.The port control scan showed some leakage at the catheter connection.Before the port was explanted, the patient felt cardiac arrhythmias and a new scan showed that the catheter lost connection to the chamber.The physician explanted the port and removed the disconnected catheter transfemoral out of the vessel.Afterwards, he trimmed the part of the catheter that had been connected to the chamber and sent this piece along with the chamber for investigation.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.A review of the dimension verification, complaint history, device history record, drawing and visual inspection was performed for the purpose of this investigation.One used mini titanium vital port was returned with this complaint.No catheter, catheter lock, or other accessories were returned.A visual inspection thus could not be performed on the catheter itself.A visual inspection of the vital port, confirmed that the suture holes were unused.No anomalies, burrs, or nicks were observed on the device or its outlet tube.A dimensional verification was performed on the outlet tub, which confirmed that the device was manufactured to specification.Manufacturing records for this device were reviewed, and no evidence of nonconformity that could lead to this complaint code was found.Because the catheter was not returned, it could not be inspected for signs of a proper connection.There is no evidence of manufacturing nonconformity based upon the vital port body that was returned.The suture holes were not used, which could contribute to longitudinal force applied to the catheter and lead to a disconnect.The customer is encouraged to read the ifu to ensure proper catheter advancement and suture hole attachment technique as used.

Manufacturer Narrative

(b)(4).Material separation is not labeled.

• Brand Name: VITAL PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Manufacturer (Section D): COOK VASCULAR INC; vandergrift PA 15690
• Manufacturer Contact: larry pool, mgr. ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 4585165
• MDR Text Key: 5448401
• Report Number: 1820334-2015-00111
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/05/2015,02/15/2015

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: 07/31/2015
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Device Lot Number: N107707
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2015
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention