MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96830-108

Device Problem Mechanical Problem (1384)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

Medtronic received information that during use of a bio-medicus cannula, the customer reported that the introducer could not be inserted up to the tip of the cannula, so it got deflected and could not be used anymore.The device was replaced to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that the tip did not appear to be blocked.However, it seemed to be narrowed, and the introducer was jammed by the tip while inserting the product into the patient's body.There was no kink in the cannula, but the introducer seems to have bent squishily inside the cannula.The tip did not detach from the cannula body.The device was used to rotate the ecmo, but only a small part of the introducer came out from the tip, so the device was used and the ecmo was rotated as is.As a result, it was not replaced with a different product.The cannula was neither heated nor cooled prior to use.

Manufacturer Narrative

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: after investigation the complaint is unconfirmed for the introducer not passing through the cannula and extending past the cannula tip, as no product has been returned to date and no photo has been provided.However, based on the available event details, it is most likely this complaint is related to a known supplier issue.The manufacturing site was notified about this and was asked to start inspection of all the product prior to release it to the field, this inspection started on october 2020 and the lot number reported within this complaint was manufactured in january 2020.It is guaranteed that no more product will be released without inspection and evidence that the product performance meets specification.Review of the device history record was not completed as this device was manufactured prior to inspection implementation to eliminate this non-conformance.A review of complaints received for similar model numbers found additional complaints related to this issue, however, as this issue has been mitigated, product manufactured on or after october 2020 should not present this issue.Assessment against the medtronic risk management file, the design failure modes, effects, and criticality analysis (dfmeca) document indicates that the current risk zone does not exceed the risk zone predicted in the product dfmeca; therefore, no corrective and preventive action (capa) will be initiated at this time.There were no adverse patient effects because of this incidence.Trends for issue with this device are monitored.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIO-MEDICUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: 16034049
• MDR Text Key: 308205550
• Report Number: 2184009-2022-00454
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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 Expiration Date: 01/25/2024
• Device Model Number: 96830-108
• Device Catalogue Number: 96830-108
• Device Lot Number: 219360750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/27/2023
• Date Device Manufactured: 01/25/2020
• 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