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

Catalog Number	H965451030
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/08/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer conducted a documentary review: product met specifications per documentary review.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) 2013, patient underwent placement of an angiodynamics xcela power injectable port catheter product, model number h965451030, lot number 121584000.The device was implanted by dr.(b)(6), m.D.(b)(6) hospital in (b)(6).The device was implanted for the purpose of ongoing venous access.On or about (b)(6) 2013, patient presented to (b)(6) hospital in (b)(6), with complaints of a redness, tenderness, and pain over the left chest, shoulder, and neck area.Patient's medical team determined that he had developed an infection.On or about (b)(6) 2013, patient's infected port was removed by dr.(b)(6), m.D., (b)(6) hospital.At no point did patient's healthcare team indicate to him that the xcela failed or was defective.Patient's healthcare providers did not state that the xcela was the cause of the infection.

• Brand Name: XCELA
• Common Device Name: PORT
• Manufacturer (Section D): PFM MEDICAL CPP SA; SZ
• Manufacturer (Section G): PFM MEDICAL CPP SA
• MDR Report Key: 22671548
• Report Number: 3008737795-2025-00016
• Device Sequence Number: 19789613
• Product Code: LJT
• UDI-Device Identifier: H965451030
• UDI-Public: H965451030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• 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): 07/30/2025

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: 121584000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown