MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	CB96570-015
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Cardiogenic Shock (2262)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
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 during use of a bio-medicus one-piece femoral arterial cannula, it was reported that at 7:00a.M.On (b)(6) 2024, the nurse in charge of the bed found that the patient's extracorporeal membrane oxygenation (ecmo) collateral circulation three-way connector was ruptured and sprayed blood.The tube was broken.Under sterile conditions, compression was applied to stop the bleeding immediately.It was reported to the doctor at the same time.The patient's vital signs were closely observed.The critically ill patient's blood pressure dropped from 130/75mmhg to 108/54mmhg.Norepinephrine was immediately given to maintain their blood pressure.The ecmo flow was adjusted lower to 1.5l/min.This issue caused the patient to bleed approximately 700ml.There were 4 units of leukocyte-reduced suspended red blood cells prepared for the patient.Continued observation and treatment were given to the patient.Under sterile operation, the doctor was assisted in replacing the ecmo collateral circulation three-way connector and the 3/8 tube of the arterial catheter to complete the procedure.
Additional Manufacturer Narrative
Medtronic received additional information that the cannula was not heated or cooled prior to use.The patient did not experience myocardial infarction and cardiogenic shock as a result of the issue.There was no blood transfusion required.The same insertion site was used to insert the replaced cannula.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: BIO-MEDICUS
• 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: 19972329
• Report Number: 9612164-2024-03688
• Device Sequence Number: 7001488
• Product Code: DWF
• UDI-Device Identifier: 00763000193355
• UDI-Public: 00763000193355
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142673
• 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): 09/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2026
• Device Model Number: CB96570-015
• Device Catalogue Number: CB96570-015
• Device Lot Number: 228543772
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/04/2024
• Date Device Manufactured: 03/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male