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

Catalog Number 44032

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Local Reaction (2035)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A patient reported experiencing an allergic reaction to an xcela 8f port.Soon after the device was implanted, the patient complained of pain and discomfort, extending from the right chest to the right shoulder.Chemotherapy was also administered on this date; however, it is unknown if reaction occurred prior to or following administration of cytarabine.Due to the localized allergic reaction, the port was explanted 6 days after insertion.A picc was inserted to provide antibiotic treatment with vancomycin and cefepine and to continue chemotherapy treatment.The patient reported that both the device and the insertion site were cultured for bacteria and found to be negative.Due to the reaction, the patient was hospitalized for a prolonged period of 27+ days but has since been discharged.Patient is still continuing antibiotic therapy and the post port-removal wound site continues to drain fluid.

Manufacturer Narrative

No port product was returned to angiodynamics for evaluation.There was no report of port device malfunction during implantation or use.The customer's reported complaint description of patient had an allergic reaction to an xcela 8f port cannot be confirmed given the patient centric nature of this serious adverse event (sae).No port device was returned for evaluation and there were no reports of port device malfunction during implantation and first use on (b)(6) 2023.First use included chemotherapy infusion of cytarabine.Root cause of the patient allergic reaction cannot be definitively be determined, however, allergic reaction to the chemotherapy drug infused (cytarabine) may be a contributing factor.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.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.Adverse events drug extravasation hematoma implantation site necrosis or infection catheter occlusion, malposition, dislodgment, fragmentation, migration, disconnection or rupture catheter occlusion or breakage caused by pinching between clavicle and first rib catheter to port connection: note: to ensure proper assembly of port and snaplock connector, a minimal gap (less than 0.5 mm) is expected.Precaution: prior to advancing the snap lock connector, ensure that the catheter is properly positioned.A catheter not advanced to the proper region may not seat securely and lead to dislodgement and extravasation.The catheter must be straight with no sign of kinking.A slight pull on the catheter is sufficient to straighten it.Advancing the snap lock over a kinked catheter may damage the catheter.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: · carefully follow the catheter to port connection technique provided in the dfu to ensure proper device connection and to avoid catheter damage.· assure tight connection between port body and catheter.· after implantation or any treatment via the port, the system should be flushed with normal saline for injection per institutional protocol.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
• Type of Device: PORT, INTERNAL, SUBCUTANEOUS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17447010
• MDR Text Key: 320287645
• Report Number: 1317056-2023-00093
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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 Operator: Health Professional
• Device Catalogue Number: 44032
• Device Lot Number: 5774820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 73 KG