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	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The tack endovascular system (tes) was used in a peripheral procedure.Upon entering the sheath, a tack was inadvertently deployed but was able to be removed from the entrance of the sheath.The procedure was completed with a stent.No patient injury reported.This product problem is being submitted because the tack inadvertently deployed.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 tack device was returned for evaluation.The inner core shaft and the corresponding stainless steel pusher feature on the proximal end of the device was in a fully deployed position.This displayed the full range of the distal portion of inner core shaft and distal inner core markers.Visual inspection found a kink on the distal portion of the inner core shaft, approx.3 inches proximal to the first inner core marker.Additionally, the outer braid sheath was kinked, approx.5 inches distal to the strain relief with deformity observed on the midpoint of the strain relief.The strain relief was cut, removed, and the outer braided shaft was inspected.Upon removal, the outer braid sheath had a kink and partial shaft breakage in the location of the strain relief deformity.During functional testing, an attempt was made for tack deployment but was unsuccessful because the stainless-steel pusher feature bond was broken at the inner core shaft.The pin and pull tack deployment mechanism was not in functional working order due to the inability to retract the outer braided sheath over the inner core shaft.After the strain relief and shaft dissection, the outer braided sheath was able to retract over the inner core shaft with resistance noted when the distal tip kink retracted through the outer braided sheath.The hemostatic valve was tested in the locked position and the locking mechanism was in working order, not allowing the pin and pull tack deployment mechanism when locked.Block h6: based on the device analysis, the root cause of the inadvertent tack deployment could not be established.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: diana melliza galvez ; 5905 nathan lane north; plymouth, MN 55442 ; 510933-4541
• MDR Report Key: 19665700
• Report Number: 3012608866-2024-00003
• Device Sequence Number: 17763257
• 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: Physician
• 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: 09/27/2023
• Device Model Number: 154150041
• Device Catalogue Number: 154150041
• Device Lot Number: 273658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• 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: 09/27/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO: 6F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE
• Patient Sex: Unknown