MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM (6F, 4.0-8.0MM); SCAFFOLD, DISSECTION REPAIR

Model Number	206135061
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The tack endovascular system (tes) was used to treat the distal sfa.The first five tacks were deployed successfully.The sixth tack was not intended to be deployed; however, the patient moved her leg, and was inadvertently deployed in the common femoral artery.An attempt was made to retrieve the tack by putting the sheath over it but could not be retrieved.A balloon was used to post dilate and to ensure proper wall apposition of the sixth tack.This adverse event and product problem is being submitted because the sixth tack was inadvertently deployed, requiring additional intervention, but retained in patient.
Additional Manufacturer Narrative
Block a2/a4: the patient's dob or age at time of event and weight are unknown.Block b6: patient information regarding relevant tests/laboratory data is unknown.Block h3: the tack device was not returned, thus no returned product investigation was performed.Block h6: based on the complaint details, the patient moved her leg causing the tack to be inadvertently deployed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 4.0-8.0MM)
• Common Device Name: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR, INC.; 5905 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): INTACT VASCULAR, INC.; 5905 nathan lane north; plymouth MN 55442
• Manufacturer Contact: diana melliza galvez ; 5905 nathan lane north; plymouth, MN 55442 ; 510933-4541
• MDR Report Key: 20599624
• Report Number: 3012608866-2024-00027
• Device Sequence Number: 8804475
• Product Code: QCT
• UDI-Device Identifier: 00850003494036
• UDI-Public: (01)00850003494036(17)241227(10))331221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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: 12/27/2024
• Device Model Number: 206135061
• Device Catalogue Number: 206135061
• Device Lot Number: 331221
• 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: 10/12/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC: 0.014" CHOICE GUIDEWIRE; TERUMO: 6F DESTINATION INTRODUCER SHEATH
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White