MAUDE Adverse Event Report: NELLCOR MEXICO SA MICROVASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	MVP-5Q
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Physician was attempting to use a microvascular plug during procedure.Resistance was felt while advancing the plug through the introducer sheath or catheter.It was reported that physician advanced mvp-5q into terumo 2.7f 130cm microcatheter and it deployed just after hub.The delivery wire was not manipulated or rotated before or during delivery of the plug through the catheter.The user did not rotate the torquer in the incorrect direction accidentally during preparation.Advancement was smooth through introducer sheath then the plugged jammed in microcatheter proximally.The reason the mvp got stuck was because the progreat 2.7f is too small for the mvp5-q.The micro catheter was in the patient when plug detached.Pushable coils were used to embolize and complete the procedure.No intervention required for device removal.No vessel damage noted.The device was safely removed from the patient.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation visual inspection: the mvp was returned with a non medtronic progreat 2.7f catheter the mvp was detached from the returned delivery wire damage was observed to the catheter of the non medtronic device the lumen of the non medtronic catheter was blockage the mvp was stuck in the proximal end of the inner lumen of non medtronic device 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: MICROVASCULAR PLUG
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): NELLCOR MEXICO SA; boulevard insurgentes 19030; tijuana CA 22225 ; MX 22225
• Manufacturer (Section G): NELLCOR MEXICO SA; boulevard insurgentes 19030; tijuana CA 22225 ; MX 22225
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15475260
• Report Number: 3007170829-2022-00010
• Device Sequence Number: 11471145
• Product Code: KRD
• UDI-Device Identifier: 00763000307790
• UDI-Public: 00763000307790
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: MVP-5Q
• Device Catalogue Number: MVP-5Q
• Device Lot Number: 213120337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 47 KG