MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO VORTEX PORT; LOW PROFILE PLASTIC VORTEX PORT

Model Number	CT80LPPDVI
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	05/15/2023
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 investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
10 days after a bioflo vortex port placement, the patient was experiencing pain and there was difficulty flushing or aspirating the port.Upon evaluation it was reported the catheter had detached from the port and moved into left subclavian.The patient required surgical removal of the catheter and a replacement device was placed.
Additional Manufacturer Narrative
Returned for evaluation was (1) bioflo vortex port.The port and catheter tubing contained biomaterial {blood} inside and out.It was also noted during the disinfection process that the catheter was occluded with bio material {blood clots} inside.The 8.0 french lock was not returned with the port sample.During visual inspection and functional check, no defects were noted to the returned sample.The catheter and stem met dimensional specifications.A lock was able to be connected and infusion and aspiration were performed without difficulty.No manufacturing non-conformances were observed.The customer's reported complaint description of difficulty flushing or aspirating the port was not confirmed.In addition, the customer reported that the catheter tubing had separated/disconnected from the port housing.The returned complaint sample included the port housing and catheter tubing (not connected), however, the locking collar was not returned.A definitive root cause for difficulty infusing/aspirating and catheter detaching could not be determined from sample review.The customer's experience with this port device could not be definitively determined, however, an unsecure connection during the port placement procedure is a potential contributing factor.Given that the port outlet tube and catheter tubing met dimensional specifications and a secure/leak free connection was able to be achieved with a locking collar from inventory, there is no indication that the catheter tubing detachment from port housing event is related to the manufacturing of the device/components.A potential contributing factor is an unsecure connection of the catheter tubing to the port housing during the placement procedure.This is also indicated by the lack of damage/fracture to the catheter tubing and the short period of time (10 days) it took for the catheter tubing to detach from the port housing.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 directions for use (dfu) that is provided in the reported kit contains the following directions and precautions: absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, pinch-off syndrome, fibrin formation, thrombosis or malposition.This should be evaluated prior to device usage.A blood return should be present prior to usage of device for any therapy or testing.If the patient complains of pain, or there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, pinch-off syndrome, thrombosis or malposition.Failure to assess these complaints or observations can lead to device failure.Precautions: to avert device damage and/or patient injury during catheter placement: 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.Potential complications: use of an angiodynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: catheter occlusion, malposition, dislodgement, fragmentation, migration, disconnection or rupture.Connecting the catheter: place catheter lock back onto catheter, orienting the catheter lock such that arrow marking points in the direction of port.Trim the catheter to proper length at a 90° angle allowing sufficient slack to permit body movement, port connection and verify that the catheter is not kinked.Advance catheter over port stem to the midway point.Advance catheter lock until it engages with tactile and/or audible feedback.To ensure proper assembly of port and catheter lock connector, a minimal gap (less than 0.5 mm) is expected.If the catheter and locking collar are connected and then disconnected, the catheter proximal end must be re-cut to ensure a safe re-connection to the port.Precaution: prior to advancing the catheter 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 catheter lock over a kinked catheter may damage the catheter.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: BIOFLO VORTEX PORT
• Common Device Name: LOW PROFILE PLASTIC VORTEX PORT
• 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: 17071829
• Report Number: 1317056-2023-00068
• Device Sequence Number: 6095454
• Product Code: LJT
• UDI-Device Identifier: H787CT80LPPDVI0
• UDI-Public: H787CT80LPPDVI0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: CT80LPPDVI
• Device Catalogue Number: CT80LPPDVI
• Device Lot Number: 5769939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 43 KG