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

Model Number H965451830

Device Problem Complete Blockage (1094)

Patient Problem No Information (3190)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

The quality records for the lot 138689 000 are complete and in order.No non-conformity was recorded for this lot number.No similar complaint has been recorded for this lot of xcela power injectable port.No deviation has been recorded in material and/or manufacturing process during manufacturing of the lot number 138689 000 of xcela power injectable port.The correct fluid pathway of every port, as well as leakage is tested during production at 100% for the dual port (according control instruction (b)(4)).And we verify unit by unit that nothing is blocking the lumen of the port pin under (according work instruction (b)(4)) no similar complaint has been reported on the last three years for xcela dual lumen port.On other type of ports, single lumen, we recorded two similar complaint: (b)(4), us market (pfm inc reference (b)(4)), article h965451030, (b)(4), european market, titanium port; it is a problem with a low recurrence rate, there is no possible link between the products of the complaints listed above, and the product of this complaint (b)(4).N.B: we recorded cases of blocked ports which cannot be injected, but only after several days/weeks/months/years of implantation, not during preparation for port insertion.Blockage caused by blood clots, drug precipitation, thrombosis, catheter flap or pinch-off.Hypothesis: three possible causes of the reported problem: the needle was not inserted entirely & consequently the bevel was inside the septum.This is very unlikely as the port is outside of the patient.The pressure to push the fluid was superior to the force they applied on the syringe pump, so, there is obstruction inside the port.It could be possible that the huber needle used was itself blocked.Conclusion: the review of the device history records, the review of similar complaints and risk management review showed no deviation.No deviation has been recorded in material and/or manufacturing process during manufacturing of the lot number 138689000 of xcela power injectable port.Without the returned product, we are not able to further the investigation.

Event Description

Dr.(b)(6) couldn't flush one side of the port.It was occluded upon insertion.Port was removed and new port was placed with implanted catheter.New port functioned fine.

• 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: 8308706
• MDR Text Key: 137529711
• Report Number: 2032582-2017-00010
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00764014511032
• UDI-Public: 0764014511032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2019

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: 02/27/2022
• Device Model Number: H965451830
• Device Catalogue Number: H965451830
• Device Lot Number: 1386890000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention