MAUDE Adverse Event Report: ANGIODYNAMICS DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 10301201

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the 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

A territory manager reported an end user experienced an issue when using a peelable sheath from a duraflow 2 procedure kit.The user reported that when they broke open the sheath, 4 very sharp "tooth like" projections are left behind that have actually cut open the user's glove during catheter insertion.The projections did not break the provider's skin.

Manufacturer Narrative

This event has been reassessed as not a reportable adverse event.Reference (b)(4).

Event Description

Upon further review by angiodynamics' post market surveillance group, it was determined this event does not meet the criteria of an adverse reportable event.There was no puncture of the provider's skin, and the provider did not experience any adverse effects, harm, or require medical intervention because of this incident.Therefore, this event has been reassessed as not reportable.This report is being submitted in order to close out the regulatory reporting record.

• Brand Name: DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16662509
• MDR Text Key: 312588520
• Report Number: 1319211-2023-00020
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H787103012015
• UDI-Public: H787103012015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 10301201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 04/26/2023
• 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