MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 10012

Device Problems Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 04/29/2024

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of a dlp aortic root cannula, the customer reported that the device was damaged/deformed.The blue piece internally broke off and the customer was unable to remove needle due to broken luer and blue piece inside.The customer also reported that the top luer connection was not working.There was no damage to the packaging.The device was replaced.There was no patient involvement, so no adverse effect occurred.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Device evaluation summary: the male luer stem of needle introducer appears to have been inadvertently bonded to the female luer during assembly and when it was removed the luer cracked/split.Reason for return was confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19211618
• MDR Text Key: 341476586
• Report Number: 2184009-2024-00265
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00613994540256
• UDI-Public: 00613994540256
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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 Model Number: 10012
• Device Catalogue Number: 10012
• Device Lot Number: 2024031210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2024
• 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