MAUDE Adverse Event Report: PFM MEDICAL INC. XCELA; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	H965451810
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of device history record: the quality records for the lot 135308000 are complete and in order.No non-conformity was recorded for this lot number.No similar complaint has been recorded for this lot.No deviation has been recorded in material and/or manufacturing process during manufacturing of the lot number 135308000.Returned product investigation.It was observed that the catheter was deformed on a 1cm section at 7.5cm from the tip.A 5mm slot on the catheter shows that the subject catheter has been clamped and declamped many times.Pinch off grade 3 is suspected.The x-ray image was not available to confirm the catheter position.According to the puncture marks observed on the septum, the port has likely been implanted for a few months.Based on the substantial time of implantation and based on observation of the returned product, it can be concluded that the leakage comes from the fracture of the catheter and such fracture is due to a pinch-off grade 3: catheter damage.Explanation: based on the information provided it is supposed that the catheter, inserted into the subclavian, was compressed between the first rib and the clavical.Such effect is very well described in literature and in the instructions for use.It is named "pinch-off".The recommended action for a grade 3 pinch-off is the prompt removal of the catheter, which was followed by the healthcare professional.Review of risk analysis: the risk of "catheter fracture" is identified in the risk analysis (per iso 14971) and evaluated with an occurence of < 0.005%.A review of complaints showed that the most frequent cause of a catheter fracture is a pinch-off grade 3.The review of the instructions for use shows detailed/adequate instruction for port catheter placement and pinch off warning.Conclusion: based on the investigation of the returned product, the reported problem is being attributes to a pinch-off grade 3.The most frequent cause of a catheter fracture in pinch-off grade 3.This risk is identified in the risk analysis and such cause is very well described in the literature and in the instructions for use.
Event or Problem Description
Port leaked in patient - accessed on side of port and patient immediately bruised.

• Brand Name: XCELA
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): PFM MEDICAL INC.; 1815 aston ave; suite 106; carlsbad CA 92008
• MDR Report Key: 6878633
• Report Number: 2032582-2017-00002
• Device Sequence Number: 116802
• Product Code: LJT
• UDI-Device Identifier: H965451810
• UDI-Public: H965451810
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2017

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 Expiration Date: 06/30/2020
• Device Model Number: H965451810
• Device Lot Number: 135308000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/20/2017
• 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: Required Intervention
• Patient Age: 7 YR