MAUDE Adverse Event Report: ANGIODYNAMICS XCELA PLUS PORT; PORT, INTERNAL, SUBCUTANEOUS

Model Number	44041
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a xcela 6f single titanium port.Due to port leakage, the provider determined to remove the indwelling port.During removal, it was noted that the device appeared to be cracked and was leaking.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was reported the patient would have a new port placed in a future procedure.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was one bioflo port.As received, approximately 25cm of the catheter and connector were attached to the xcela plus port.The port septum and catheter tubing contained bio material {blood} inside and outside.Some discoloration was noted to the distal tip of the catheter.Manufacturing engineer performed leak test of assembled device as received.No leaks/cracks were observed.The device met all manufacturing dimensional specifications.The catheter was clamped closed and the port was pressurized with air at 50 psi.The port was then submerged under water to monitor for leaks.No leaks were detected.The customer's complaint description of port leakage or catheter cracked could not be confirmed during sample review.No manufacturing non-conformances were observed during sample evaluation.Dhr search was performed on lots noted in recent ship history and revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Root cause of this event could not be definitely determined.A review of the device history records was performed for the reported 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.Labeling review: the dfu contains the following precautions: precautions: carefully read and follow all instructions prior to use.Only licensed health care practitioners should insert, manipulate, and remove these devices.Intended use/ indications for use: the bioflo port with endexo technology, bioflo dual port with endexo technology and the bioflo port with endexo and pasv valve technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products.The device is also indicated for blood specimen withdrawal.Maintenance: to help prevent clot formation and catheter blockage, the bioflo port should be filled with sterile heparinized saline after each use.Bioflo ports with the pasv valve may be flushed and locked with either normal saline or heparinized saline per institutional protocol.If the port remains unused for long periods of time, the lock should be changed at least once every four weeks.Precaution: some patients may be hypersensitive to heparin or suffer from heparin induced thrombocytopenia (hit) and these patients must not have their port primed with heparinized saline a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: XCELA PLUS PORT
• Common Device Name: PORT, INTERNAL, SUBCUTANEOUS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 10542171
• Report Number: 1317056-2020-00147
• Device Sequence Number: 14153856
• Product Code: LJT
• UDI-Device Identifier: H965440410
• UDI-Public: H965440410
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 44041
• Device Catalogue Number: 44041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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: Other