MAUDE Adverse Event Report: COOK VASCULAR INC. VITAL PORT DETACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

Catalog Number IP-S9110

Device Problem Occlusion Within Device (1423)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

There was an occlusion within the vital port silicone catheter three days after implantation.No additional info regarding pt or pt outcome has been provided.

Manufacturer Narrative

The event is currently under investigation.

Manufacturer Narrative

A review of complaint history, device history record, and instructions for use (ifu) was conducted during the investigation.Manufacturing records for this device were reviewed, and no evidence of nonconformity was found that could create an occlusion within the device.There is no evidence to suggest the product was not manufactured to specification.Because the device was not returned for evaluation, no images were provided, and no information about the location of the occlusion was provided, the root cause of this complaint cannot be determined.The customer is encouraged to review the ifu to ensure the catheter is cut squarely, the proper type of needle is used, and proper flushing protocol is followed.The appropriate internal personnel has been notified and will continue to monitor similar complaints.

Event Description

The patient did not require any additional procedures due to this occurrence according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: VITAL PORT DETACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
• Manufacturer (Section D): COOK VASCULAR INC.; vandergrift PA 15690
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4574738
• MDR Text Key: 5559549
• Report Number: 1820334-2015-00109
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00827002264403
• UDI-Public: (01)00827002264403(17)160831(10)N115451
• Combination Product (y/n): N
• Reporter Country Code: JO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: IP-S9110
• Device Lot Number: N115451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/03/2015
• Device Age: 17 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other