MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / SMARTPORT; PORT & CATHETER, IMPLANTED

Device Problem Crack (1135)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Although no sample is expected to be returned, angiodynamics has reached out to the complaint reporter to try to obtain additional details of the event and the device used.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported by angiodynamics' distributor in poland, a hospital removed a smart port one year after implantation.The removed catheter exhibited a hole in the tubing.No patient complications were reported.No product is being returned to angiodynamics, however a photograph was provided.

Manufacturer Narrative

The reporting facility did not indicate the lot/batch of the affected product.Therefore no device history records review was conducted.A shipping history lot review was not performed as the item number of the device was also unknown.The (b)(6) 2017 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter fractured." no adverse trend was indicated.Although a device sample was not returned to angiodynamics, the hospital did provide a picture of the reported defect.Based on the photo supplied, the complaint of "hole/slice" is deemed confirmed.The hole/slice was approximately 9cm from the port.The hole in the catheter is observed to be a longitudinal slice.Without receiving product for evaluation, however, we are unable to definitively determine a root cause for this incident.Potential root cause of this failure is "pinch off syndrome" or over-pressurization of the port device.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" and over-pressurization of the port device.(b)(4).

• Brand Name: ANGIODYNAMICS / SMARTPORT
• Type of Device: PORT & CATHETER, IMPLANTED
• 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 ; 5187424488
• MDR Report Key: 7120522
• MDR Text Key: 95732626
• Report Number: 1056436-2017-00130
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K062414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• 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