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

Model Number 96570-119

Device Problem Material Separation (1562)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a 96570-119 bio-medicus nextgen femoral arterial cannula, the patient was cannulated for surgery.On thursday (b)(6) 2020) they tried to remove it.However, a piece of the cannula was still in the patient.The point of separation was the joint between the body of the cannula and the dispersion tip, not a suture point.The physician was unable to retrieve it.Vascular surgery was consulted to take the patient to the or to remove the piece of the cannula still left in the patient.The tip remains in the artery.The patient is too sick to take back to the or to remove it at this time.There is flow to the leg.

Event Description

Medtronic received information that during use of a 96570-119 bio-medicus nextgen femoral arterial cannula, the patient was cannulated for surgery.On the same day they tried to remove it, however, a piece of the cannula was still in the patient.The point of separation was the joint between the body of the cannula and the dispersion tip, not a suture point.The physician was unable to retrieve it.Vascular surgery was consulted to take the patient to the or to remove the piece of the cannula still left in the patient.The tip remained in the artery.The patient was too sick to take back to the operating room (or) to remove it at the time but was described as doing okay and there was flow to the leg.The patient was brought in the following week, underwent intraoperative fluoroscopy in the or and then a procedure was done to successfully remove the tip.Patient status was described as doing fine.Additional information received from the customer: patient was a congenital etiology.No calcification was noted in the patient.Patient did have a congenital heart surgery.Case was a cardiac surgery patient, not ecmo.Cannula in use for 1.5 -2 hours when they tried to remove it.

Manufacturer Narrative

Medtronic investigation and conclusion: analysis found the tip of the cannula being separated.After analysis the cause of this complaint could not be determined.However, it is deemed that a severe physical shock would be needed to inflict damage on this design.Throughout the assembly process each device is 100% visually inspected, manufacturing controls are in place for the inspection of each device to ensure that product meets specification prior to the release from the manufacturing facility.Within medtronic control, no damage reports were received through sterilization or distribution centers.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Assessment against the medtronic risk management file indicates that the current risk zone does not exceed the risk zone predicted; therefore, no capa will be initiated at this time.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.

Manufacturer Narrative

¿6.Patient codes (ime/annex e): additional fdp code added to this complaint event: c4080 (perforation) resulting in 2 additional ime/annex e codes: 1.E200801 (device embedded in tissue or plaque) 2.E2114 (perforation).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): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc MN 22570 ; MX 22570
• MDR Report Key: 10599740
• MDR Text Key: 208966843
• Report Number: 9612164-2020-03679
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2021

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 Operator: Health Professional
• Device Expiration Date: 05/25/2024
• Device Model Number: 96570-119
• Device Catalogue Number: 96570-119
• Device Lot Number: 220085682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 03/22/2021
• Supplement Dates FDA Received: 11/13/2020; 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization