MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX CT PORT ACCESS SYSTEM; SMARTPORT CT

Catalog Number	H787CT80STPAVI1
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference: (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2017: patient was receiving chemotherapy via port.The port was flushed 6-8 weeks if not in use.This port was currently in used weekly.When flushing the port, the patient reported experiencing slight pain.It was noted the port catheter had fractured.It was reported the defective device was removed.The patient did not suffer any adverse effect due to this event.It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
As no sample was returned, angiodynamics was unable to perform a device evaluation.However, based on samples returned for similar complaints from this reporting customer, the reported complaint description of catheter fracture is confirmed.Angiodynamics had received three (3) smartports.One with no catheter tubing (labeled as sample #1) and 2 ports with catheter tubing (samples #2 and #3).There was no distinction between the port samples returned and the multiple complaint files opened based on the customer's reported occurrences, so the complaint samples were assigned a sample number and complaint file number, and investigated individually.A medwatch has been created for each complaint file.A visual inspection of sample returned with tubing was performed using magnification.As received, the catheter tubing was fractured.The customer's reported complaint description of "catheter fractured" is confirmed, as the samples were returned with the catheter tubing fractured.The catheters exhibited a crushing fatigue failure of the catheter tubing.This, along with the location of the fracture being 4-6cm from the port body indicate "pinch-off" syndrome as likely root cause for the catheter fracture.Although the complaint description is confirmed, a definitive root cause for the reported complaint description cannot be determined.A potential root cause of this failure is "pinch off syndrome".The directions for use supplied with the device instructs the physician/clinician on how to properly implant the catheter/port, and cautions against certain handling techniques to avoid "pinch-off syndrome".A review of the device history records was performed for the indicated 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.The instructions for use, which is supplied to the user with this catalog number, contains the following statements: potential complications: catheter fragmentation and catheter pinch-off.Catheter placement considerations: warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.Pinch-off syndrome: pinch-off syndrome signs may include difficulty in aspirating blood, resistance to flushing or infusion of medications or fluids that improves with position changes, infraclavicular pain and/or swelling with catheter flushing or infusion palpitations, sudden onset chest pain, cardiac arrhythmias, extra heart sound, chest wall swelling at the port pocket, vein insertion site, pain in shoulder or port area not associated with swelling, cough, paresthesia of arm on side of catheter withdrawal occlusion or swishing sound with catheter flushing.Warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.Note: if infusion or aspiration is successful upon lifting arm above the head and turning the head, consider pinch-off syndrome as a possible cause.The line should be radiologically evaluated if pinch-off syndrome is suspected.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.Complaint reference (b)(4).

• Brand Name: VORTEX CT PORT ACCESS SYSTEM
• Common Device Name: SMARTPORT CT
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6508026
• Report Number: 1056436-2017-00074
• Device Sequence Number: 1594585
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPAVI1
• UDI-Public: H787CT80STPAVI1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: Physician Assistant
• Device Catalogue Number: H787CT80STPAVI1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR