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

Model Number 96570-121

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 09/26/2022

Event Type  Injury  

Event Description

Medtronic received information that during use of a bio-medicus nextgen femoral arterial or jugular venous cannula, it was reported that the customer observed bleeding from the cannulation site and when they tried to treat the bleeding at the site, the cannulae unintentionally slipped out of the patient's body while the suture ring remained fixed. the customer stated that it took ten to twenty minutes to re-insert the cannula and resume extracorporeal circulation.During that time cardiac arrest occurred.Veno-arterial extra corporeal membrane oxygenation (v-a ecmo)  is still in operation. the device was used to complete the procedure.There was no additional patient impact associated with this event.The customer stated that the cannula was used as a femoral arterial cannulae during an aortic replacement procedure the previous day. the cannula continued to be used as a femoral arterial cannulae for v-a ecmo because the patient had difficulty weaning from extracorporeal circulation.Medtronic received additional information that the difficulty weaning from extracorporeal circulation was due to poor cardiac function after surgery.It was not due to an issue with the cannula.The cannula slipped out when the doctor touched it to identify the bleeding site.The amount of blood loss because of the issue is unknown.The patient required a transfusion because of the blood loss.The suture ring did not fall into the patient.The cardiac arrest was treated with cardiac massage, and assisted circulation was resumed by cannulating the opposite leg.Prior to the cannula slipping out it had been fixed only to the suture ring.The customer did not observe any damage to the cannula.The customer stated that the bleeding was probably from a leak from the cannula because the sending blood splattered outside when the cannula slipped out.

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

Device evaluation summary: visual inspection shows no outward signs of damage.The collar id and the cannula body od were measured using a keyence vision scope.Suture collar id was measured to be 0.290 inches, the specification, (b)(4) has the id to be 0.286 +/- 0.005 inches.Cannula body od was measured to be 0.304 inches, the specification, (b)(4) has the od to be 0.289 to 0.317 inches.The suture collar appears to be tight on the cannula body.Reason for return was not confirmed.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 bleeding at the cannulation site because of a leak from the cannula.There was no observed damage to the device and performance testing indicated that the device functions as intended.The suture ring appeared tight on the cannula body and both the suture ring and cannula body are within manufacturing specifications.It is unknown what may have caused this occurrence.The device history record was not reviewed as returned product analysis found no evidence of manufacturing issues with the returned device.Complaints received for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Trends for issues 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 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: 15649800
• MDR Text Key: 302171106
• Report Number: 2184009-2022-00280
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142673
• 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,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96570-121
• Device Catalogue Number: 96570-121
• Device Lot Number: 223962801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 10/25/2022; 12/20/2022
• Supplement Dates FDA Received: 11/21/2022; 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG