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

Model Number 96570-117

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Perforation of Vessels (2135)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Literature details: title: early results of robotically assisted congenital cardiac surgery: analysis of 242 patients authors: burak onan, md, and ismihan selen onan, md journal: the society of thoracic surgeons, 2021 112:2020-8.Doi.Org/10.1016/j.Athoracsur.2020.10.028.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.

Event Description

Medtronic received information via literature regarding robotic surgery as an alternative to traditional and minimally invasive cardiac procedures.All data were collected from a single center between may 2013 and february 2020.The study population included 242 patients (predominantly female; mean age 31 years), all of which were treated with medtronic dlp and bio-medicus cannulae (serial numbers not provided).Among all patients, adverse events included: femoral artery laceration in one patient.Graft replacement was done for femoral artery injury.Based on the available information, these adverse events may have been attributed to medtronic product.Among all patients, device malfunctions included: failure to cannulate the right jugular vein using the dlp cannulae in two patients.The left jugular vein was cannulated instead in both cases.Based on the available information, these malfunctions may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaint of femoral artery laceration using the nextgen bio-medicus cannula, as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.Discussion with medtronic medical safety was conducted on 13 february 2023 and review concluded none of the adverse events reported a device malfunction that would have caused or resulted in the reported adverse event.Laceration is not a new or unexpected adverse event associated with the use of these cannula devices and is predicted as known or foreseeable risk within risk management documentation.The device history record could not be reviewed as no lot number was provided.Complaints received from june 2012 through february 2023 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic will continue to monitor for future occurrences and trends.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 NG ARTERIAL 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: 15903838
• MDR Text Key: 304685229
• Report Number: 2184009-2022-00390
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96570-117
• Device Catalogue Number: 96570-117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 64 KG