MAUDE Adverse Event Report: PFM MEDICAL CPP SA XCELA; PORT AND CATHETER

Model Number H965451270

Device Problem Complete Blockage (1094)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Dhr was reviewed and no issues were found.No non-conformities, similar complaint or deviation have been recorded for the subject lot number.Difficulty to get blood return could be a sign of catheter pinch-off or catheter flap.Catheter flap is probable cause of the reported problem.Catheter flap explanation: the catheter moved from its implanted position, the tip of the catheter was back up and a flap occurred.A flap could be created if the tip of the catheter is too close to the vessel wall (with the extremity of the catheter oriented to the vessel wall).During the aspiration the vessel wall is aspirated and come to close the extremity of the catheter.

Event Description

The lead tech called and said the port was defective.They were unable to get any blood draw once implanted.The physician has been using these ports for years.So he is very familiar with them.They had to remove and open up another kit and start the procedure over.

• Brand Name: XCELA
• Type of Device: PORT AND CATHETER
• Manufacturer (Section D): PFM MEDICAL CPP SA; allée du quartz 9; la chaux-de-fonds, 2300 ; SZ 2300
• Manufacturer (Section G): PFM MEDICAL CPP SA; allée du quartz 9; la chaux-de-fonds, 2300 ; SZ 2300
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008
• MDR Report Key: 8308702
• MDR Text Key: 137001130
• Report Number: 2032582-2017-00009
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00764011098533
• UDI-Public: 0764011098533
• Combination Product (y/n): N
• PMA/PMN Number: K072481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2022
• Device Model Number: H965451270
• Device Catalogue Number: H965451270
• Device Lot Number: 139101000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention