MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO VORTEX PORT; SMARTPORT+ LOW PROFILE PORT WITH ENDEXO AND VORTEX TECHNOLOGY

Model Number CT80LPPDVI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/17/2021

Event Type  malfunction  

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

An interventional radiology lead technician reported an issue with a 8f low profile plastic vortex port detached poly catheter filled sh valved introducer.During a procedure, a physician was implanting the port into a patient and, as the sheath was being peeled, it cut the doctor on his finger.The procedure was completed with this device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.The doctor required blood tests after the cut.The reported device is not available to be returned to the manufacturer for evaluation.

Event Description

Additional event information: the sheath has been peeled properly, but needed heavy force to break it apart.The opening of the sheath was where the physician received the cut.

Manufacturer Narrative

Reference (b)(4).

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of sheath was hard to break apart and cut the clinician's finger during use cannot be confirmed, no sheath sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The sheath component is supplied to angiodynamics by the sheath manufacturer, greatbatch medical.They were notified of this event per fyi scar004401, for informational purpose only as there was no sample returned and no lot number reported (provided shr lot).In addition, this is the only reported complaint for this failure mode in the past 15 months for the bioflo vortex port product family, as such, this is deemed to be an isolated incident.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: dfu peelable introducer instructions note: if using an introducer system other than that included with the smartport+ or smartport plastic device, consult that manufacturer's instructions for use.Precaution: when using an introducer kit, verify that the catheter fits easily through the introducer sheath.1.Flush introducer with saline prior to use.2.Insert the dilator through the sheath and lock in place.3.Make a small incision to facilitate advancement of dilator/sheath assembly over the guidewire, taking care not to allow contact of scalpel with wire.4.Thread the dilator/sheath assembly over the guidewire.Precaution: carefully insert the introducer over the guidewire to avoid inadvertent penetration to vital structures in the thorax.To avoid blood vessel damage, do not allow the percutaneous introducer sheath to remain indwelling in the blood vessel without the internal support of a catheter or dilator.Simultaneously advance the sheath and dilator with rotational motion to help prevent sheath damage.Note: fluoroscopic observation may be advisable.Attaching a clamp or hemostat to the proximal end of the guidewire will prevent inadvertently advancing the guidewire entirely into the patient.5.Unlock the dilator from the sheath handle by turning the dilator collar counter clockwise.6.Gently remove the dilator and guidewire, leaving the sheath as a conduit to the vessel.Warning: if using a non-valved introducer sheath, hold thumb over the exposed opening of sheath to prevent air embolism.The risk of air embolism is reduced by performing this part of the procedure with the patient performing the valsalva maneuver.7.Advance the catheter through the sheath and into the vessel.Note: to prevent kinking the catheter, it may be necessary to advance in small steps by grasping the catheter close to the sheath.Some resistance may be felt when advancing the catheter.Precautions: avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.8.When the catheter is properly positioned, crack and peel the sheath handle in half and continue to pull so that the sheath separates longitudinally while withdrawing the sheath from the vein.Make sure the catheter is not dislodged from the vessel.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
• Type of Device: SMARTPORT+ LOW PROFILE PORT WITH ENDEXO AND VORTEX TECHNOLOGY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 12407811
• MDR Text Key: 271522458
• Report Number: 1317056-2021-00164
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80LPPDVI0
• UDI-Public: H787CT80LPPDVI0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CT80LPPDVI
• Device Catalogue Number: CT80LPPDVI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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