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

Catalog Number	H965451030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer conducted a documentary review only.Without returned product for technical investigation, it is not possible to confirm the reported defect.The related risks are identified in our risk management file and procedure clearly described in the ifu.Therefore, complaint is classified as no definitive conclusion, unverifiable (no return product).
Event or Problem Description
On or about (b)(6), 2016, patient underwent placement of the angiodynamics xcela power injectable port, lot number 135896000, reference number h965451030.The device was implanted by (b)(6), md, at (b)(6), colorado, for the purpose of chemotherapy.On or about (b)(6), 2017, patient was presented to (b)(6) hospital in (b)(6), colorado where patient was diagnosed with pulmonary embolism.The port was later removed on (b)(6), 2018 at the same hospital.

• Brand Name: XCELA
• Common Device Name: PORT
• Manufacturer (Section D): PFM MEDICAL CPP SA
• MDR Report Key: 25382313
• Report Number: 3008797795-2026-00016
• Device Sequence Number: 9324620
• Product Code: LJT
• UDI-Device Identifier: 07640110982211
• UDI-Public: 07640110982211
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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 Catalogue Number: H965451030
• Device Lot Number: 135896000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown