MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5MM); SCAFFOLD, DISSECTION REPAIR

Model Number	154150041
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The tack endovascular system (tes) was used in a peripheral procedure.During use, a tack was deployed successfully.However, during removal, the tes got stuck on a 0.014" non-philips guidewire and had to be removed as a system.The procedure was completed with a new guidewire in order to deliver a balloon for post dilation.No patient injury reported.This product problem is being submitted due to removal as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
Block a: the patient's dob or age at time of event, sex, gender, weight, ethnicity, and race are unknown.Block b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.Block h3: the tes catheter was returned with a non-philips 0.014" guidewire.Visual inspection of the catheter found multiple kinks and bends on the shaft.Additionally, the distal tip was partially retracted into the outer sheath.Visual inspection of the guidewire also had multiple kinks and bends with missing coating throughout.During functional testing, a laboratory 0.014" guidewire was unable to pass through due to the damage observed.Block h6: a probable root cause may be due to the damaged observed on the non-philips guidewire; however, the cause could not be established.A review of the lhr and manufacturing process could not confirm a cause related to design and/or process failure.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 (4F, 1.5-4.5MM)
• 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: ana tan ; 5905 nathan lane north; plymouth, MN 55442 ; 858720-4037
• MDR Report Key: 19672022
• Report Number: 3012608866-2024-00021
• Device Sequence Number: 6579005
• Product Code: QCT
• UDI-Device Identifier: 00863328000196
• UDI-Public: (01)00863328000196
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 05/09/2025
• Device Model Number: 154150041
• Device Catalogue Number: 154150041
• Device Lot Number: 336136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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: 0.014" GUIDEWIRE, UNK MFG; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown