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	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The tack endovascular system (tes) was used in a peripheral procedure.During use, the tes got stuck on a 0.014" non-philips guidewire and had to be removed as a system.An extended balloon was used to complete the procedure.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 device was returned for evaluation.Visual inspection found no unusual characteristics of the device.During functional testing, a laboratory 0.014" guidewire was used, but was unable to insert through the device due to an occluded inner lumen.When attempting to deploy the tacks, the outer sheath was stuck and did not move as the pusher shaft was being pushed.The outer sheath was pushed back manually, then it was able to move by using the pusher shaft.The tacks deployed but possible dried contrast was observed on the distal tip.In order to attempt insertion of the guidewire into the lumen of the remaining shaft, the distal tip was cut to remove the occlusion.However, the tip was distorted from being cut and the guidewire was unable to advance without kinking the shaft due to resistance noted.Block h6: the root cause could not be established due to the inability to advance the guidewire during the functional testing.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: 19671664
• Report Number: 3012608866-2024-00018
• Device Sequence Number: 17855297
• 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): N
• 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: 02/04/2024
• Device Model Number: 154150041
• Device Catalogue Number: 154150041
• Device Lot Number: 301643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• 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: 02/04/2022
• 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: ASAHI: 0.014" MONGO GUIDEWIRE; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown