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

Model Number 96553

Device Problems Mechanical Problem (1384); Material Separation (1562); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Medtronic received information that during use of a bio-medicus nextgen cannula, the customer reported that they had difficulty with the wire kinking while putting a patient on extracorporeal membrane oxygenation.The customer reported that there was not really a problem with the wire but that they had a lot of resistance getting the larger dilator behind the clavicle, at which point the wire kinked.The customer tried to get behind the kink, however, it came out of the vein and broke at the site of the kink while trying to pull it out.The tip of the wire broke off and is now retained in the soft tissue.The customer stated that they do not plan to go looking for the tiny piece of wire which is inert and should not cause problems in the future.The customer has reached out requesting information regarding the material composition of the wire in order to share that with their mri safety team to assist with any recommendations for future mri safety for the patient.The material composition was provided to the customer by the cannula team.The device was replaced to complete the procedure.The patient is now off extracorporeal membrane oxygenation and is doing fine.Medtronic received additional information that the cannula was not heated or cooled prior to use.The damage was at the tip of the g uidewire which was in the patient.There was no kink in the cannula, only the tip of the guidewire.Medtronic received additional information that the customer received the mri information they were looking for.

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.

• Brand Name: BIO-MEDICUS STANDARD INSERTION KIT
• Type of Device: 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: 18138562
• MDR Text Key: 328113571
• Report Number: 9612164-2023-05242
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2023

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 Model Number: 96553
• Device Catalogue Number: 96553
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other