MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / VORTEX; VASCULAR ACCESS PORT

Device Problem Misassembly by Users (3133)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

A review of the device history records for the vortex port was not performed as no part number or lot number were provided.The angiodynamics complaint report was reviewed for the product family of vortex ports and the failure mode, " user error." no adverse trends were identified.The instructions for use, which is supplied to the user with this catalog number, contains the following statements: "potential complications: use of angiodynamics port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: fibrin sheath, migration, catheter pinch-off (compression of the catheter between the clavicle and the first rib) and catheter fragmentation.System assembly: the blue boot strain relief as on vortex® port and titanport® implantable port slide the boot over the end of the heparinized catheter.The tapered end of the boot should point away from the proximal end of the catheter.Dry the outlet tube and the proximal end of the catheter.Slide the trimmed end of the catheter tip onto the stem until the catheter is flush with the stem flanges.Slide the boot over the catheter and onto the stem until the boot contacts the port body." corrective action at the reporting facility has been addressed by the incorrect placement being "discussed and remedied locally." ((b)(4).Device discarded at hospital.

Event Description

Angiodynamics was notified by the mhra in the (b)(6) of a hospital in which the physician placed a vortex vascular access port not in accordance with the device instructions for use.Specifically, the collar was attached backwards resulting in the catheter detaching from the port.The device was removed without difficulty and the port was replaced.There was no injury to the patient, only the premature removal/replacement of the port.The used device was discarded at the hospital.

• Brand Name: ANGIODYNAMICS / VORTEX
• Type of Device: VASCULAR ACCESS PORT
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• Manufacturer (Section G): ANGIODYNAMICS; one horizon way; manchester GA 31816
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801
• MDR Report Key: 6605916
• MDR Text Key: 76451127
• Report Number: 1056436-2017-00084
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/01/2017
• 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
• Patient Outcome(s): Required Intervention