MAUDE Adverse Event Report: PFM MEDICAL ANGIODYNAMICS / XCELA; PORT & CATHETER IMPLANTED

Catalog Number	H965451810
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device from the reported event has been returned to angiodynamics.As this port is manufactured for angiodynamics by pfm medical, it is being forward to pfm for evaluation and completion of a scar (supplier corrective action request).Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4).
Event or Problem Description
Event called in by the mother of the patient.An xcela power injectable port was removed on (b)(6) 2017.The reported description of the event was : " port leaked in patient - accessed on side of port on ((b)(6) and patient immediately bruised." the port was removed at children's hospital of orange county and they have returned the device to angiodynamics.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The july 2017 angiodynamics complaint report was reviewed for the xcela ports product family and the failure mode "leakage." no adverse trend was identified.As the reported catheter is a purchased device for angiodynamics, it was forwarded to our supplier, pfm medical, along with a supplier corrective action request (scar).Their response indicated that as received, the catheter tubing wa attached to the port.The catheter was noted to be deformed on a 1cm section located 7.5cm from the tip.A 5mm slit on the catheter indicated that the catheter had been clampled and unclamped many times.From the amount of puncture marks on the septum the port had likely been implanted for several months.Based on the estimated time of implantation, and the condition of the returned device, the leakage was caused by the slit in the catheter which is consistent with "pinch-off." the directions for use supplied with the device instructs the physician/clinician on how to properly implant the catheter/port, and cautions against certain handling techniques to avoid "pinch-off syndrome," a potential complication.(b)(4).

• Brand Name: ANGIODYNAMICS / XCELA
• Common Device Name: PORT & CATHETER IMPLANTED
• Manufacturer (Section D): PFM MEDICAL; 1815 aston ave; suite 106; carlsbad CA 92008
• MDR Report Key: 6777833
• Report Number: 1317056-2017-00060
• Device Sequence Number: 13702850
• Product Code: LJT
• UDI-Device Identifier: H965451810
• UDI-Public: H965451810
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: H965451810
• Device Lot Number: 135308000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR