MAUDE Adverse Event Report: MEDTRONIC MEXICO PEDIATRIC BIOMEDICUS FEMORAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96820-108
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of the bio-medicus nextgen pediatric arterial cannulae the customer noted that when the obturator was introduced into the cannulae the obturator would bend and it would not pass through the tip of the cannulae.The cannulae were replaced for the procedure.There was no patient involvement so no adverse patient effects occurred.The customer had three instances of this occur; two of them were saved and are being returned and one of them was discarded.All of the cases occurred on the same date.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the 2 opened devices shows the introducer tip is protruding out of the tip.The introducer appears to be deformed inside the body of both cannula.The introducer insertion force appears to be tight on both devices.Reason for return was confirmed.Conclusion: complaint is confirmed for introducer not passing through the cannula.After analysis this complaint was determined to be a supplier-related issue.Supplier was notified to address this issue; meanwhile medtronic tijuana is reviewing the product before being released to distribution to eliminate any issue on the field.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Assessment against the medtronic risk management file dfmeca document indicates that the current risk zone does not exceed the risk zone predicted in the product dfmeca.There were no adverse patient effects as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: PEDIATRIC BIOMEDICUS FEMORAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17256033
• Report Number: 9612164-2023-02996
• Device Sequence Number: 7966651
• Product Code: DWF
• UDI-Device Identifier: 00643169623095
• UDI-Public: 00643169623095
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K143083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: 96820-108
• Device Catalogue Number: 96820-108
• Device Lot Number: 221600571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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