MAUDE Adverse Event Report: PFM MEDICAL CPP SA XCELA POWER INJECTBALE PORT

Model Number H965451090

Device Problem Difficult to Flush (1251)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

Date event was determined to be reportable based on additional information received was 02/18/2020. Failure classification: leak or obstruction. Inventory review: none left in stock. Dhr review: no non-conformances observed that could contribute to this issue. All in process testing passed for leaks. No testing is performed for obstructions. Investigation of returned product: after further investigation of the returned product, it appears that a blood clot formed at the entrance of the pin connector. Indeed rinsing was not possible with an obstruction in the component. Risk management review: the risk is identified in the product risk analysis and frequency is acceptable. Unable to determine root cause of the blood clot inside the port body. Likely the blood clot was aspirated out of the patient during insertion and the remaining blood in the port body coagulated around it.

Event Description

Port was not flushing properly when preparing it for a patient. The issue occurred when the device was implanted in the patient. We flush all catheters and ports prior to insertion with injectable saline. Port was placed and when the surgeon checked to see how well it flushed it would not flush. When they disconnected the port from the catheter it did flush. After placing back in the patient and checking again and a few more times each time the port was connected to the catheter to check for placement it would not flush. New port was then obtained and placed.

• Brand Name: XCELA
• Type of Device: POWER INJECTBALE PORT
• Manufacturer (Section D): PFM MEDICAL CPP SA; 9, allée du quartz; 2300 la chaux-de-fonds, ; SZ
• Manufacturer (Section G): PFM MEDICAL CPP SA; 9, allée du quartz; 2300 la chaux-de-fonds, ; SZ
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, ca ; 7588749
• MDR Report Key: 9721483
• MDR Text Key: 205350089
• Report Number: 2032582-2020-00002
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: H965451090
• Device Catalogue Number: H965451090
• Device Lot Number: 142624000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/18/2020 Patient Sequence Number: 1