MAUDE Adverse Event Report: CONTEGO MEDICAL, INC. VANGUARD; VANGUARD IEP PERIPHERAL BALLOON ANGIOPLASTY SYSTEM WITH IEP

Model Number	V1-6200-135-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mdr is being filed as a conservative measure.There were no patient sequela, and full flow was restored to the limb.The results of the investigation are attached.
Event or Problem Description
One patient involved.Dr (b)(6) was treating a diffusively diseased sfa with significant calcium in a patient with single vessel runoff he decided to use a vanguard 6x200mm to prevent any distal emboli he did two separate inflations in the diseased vessel after he was satisfied with the result was fully deflated, he closed the filter and began to withdraw the device-as filter met the 6fr sheath he got significant resistance coming into the sheath.-dr (b)(6) repositioned the catheter and sheath a few times under fluoro and was still having trouble pulling catheter into the sheath at some point he realized the filter was deformed and could not exit the sheath.He decided to pull the entire sheath and vanguard catheter out through the access site.He was unable to do so and he also noticed at this point the filter had detached from the catheter dr (b)(6) went in and tried several maneuvers to get the now detached filter out of the vessel to no avail.At this point he had done enough to have the filter, which was now just a wire pressed against the wall of the common femoral, not obstructing flow at all.-dr (b)(6) left this and his plan as he stated was to most likely go back in when the patient returns (presumably for another procedure) and potentially stent the remaining filter against the wall of the vessel.He did say the patient does not want surgery under any circumstance.

• Brand Name: VANGUARD
• Common Device Name: VANGUARD IEP PERIPHERAL BALLOON ANGIOPLASTY SYSTEM WITH IEP
• Manufacturer (Section D): CONTEGO MEDICAL, INC.; 3801 lake boone trail,; suite 100; raleigh NC 27607
• Manufacturer (Section G): CONTEGO MEDICAL, INC.; 3801 lake boone trail; suite 100; raleigh NC 27607
• Manufacturer Contact: jim clossick ; 3801 lake boone trail,; suite 100; raleigh, NC 27607 ; 3056071708
• MDR Report Key: 19956803
• Report Number: 3011471056-2024-00009
• Device Sequence Number: 20602960
• Product Code: LIT
• UDI-Device Identifier: 00851616007149
• UDI-Public: 00851616007149
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K181529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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: 11/16/2024
• Device Model Number: V1-6200-135-01
• Device Catalogue Number: V1-6200-135-01
• Device Lot Number: Z2459822B
• 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: 07/10/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose