MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT HEART VENT CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	12110
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Medtronic received information that at an unspecified time, this dlp left heart vent catheters had an issue and does not retain its shape despite the presence of the metal rod.Failure to maintain the desired shape leads to a risk of heart injury (pulmonary vein, left atrium or left ventricle) in 2-year-olds.The problem recurred 2 times in a row and 8 cannulas were opened out of the 10 contained in a box, and all had the same defect.The surgeon had to change the batch number (not communicated) in order to complete the procedure successfully.There were no clinical consequences for the child., and no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Update to b5: medtronic received information that prior to use of these dlp left heart vent catheters, it was reported that the devices did not retain their shape despite the presence of the metal rods.It was stated that a failure to maintain the desired shape could lead to a risk of heart injury (pulmonary vein, left atrium or left ventricle) in 2-year-olds.The problem recurred 2 times in a row and 8 cannulae were opened out of the 10 contained in a box, and all had the same defect.The surgeon had to change the batch number in order to complete the procedure successfully.There was no patient involvement, so no adverse effect occurred.Correction d4: expiration date added.Correction h4: device mfg date added.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 LEFT HEART VENT CATHETER
• Common Device Name: 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: 20350433
• Report Number: 2184009-2024-00587
• Device Sequence Number: 7842496
• Product Code: DWF
• UDI-Device Identifier: 00643169880672
• UDI-Public: 00643169880672
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K834039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: 12110
• Device Catalogue Number: 12110
• Device Lot Number: 2024030359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown