MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; CATHETER, PERCUTANEOUS

Model Number	A2025-040
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, patient presented to the peripheral vascular lab for re vascularization of her right anterior tibial artery.A right lower extremity angiogram showed up a patent common femoral deep femoral artery.The superficial femoral artery was patent but diffusely diseased.The popliteal artery was diffusely diseased.The tibio personal trunk was patent but the posterior tibial and perennial arteries were diseased.Runoff noted via the anterior tibial artery which had a high-grade stenosis proximately.Per the operative note, an advantage glidewire passed up and over by a 6 french sheath.The popliteal artery was accessed and the advantage glidewire was placed into the anterior tibial artery.The wire was then exchanged or v 14 wire.Angioplasty was then performed of the popliteal and provisional femoral artery using a 4x300 balloon.Repeat imaging show residual stenosis in the proximal superficial artery, a 6x100 self-expanding stent was placed which was post dilated into a 4mm.Repeat angioplasty was performed of the below the knee popliteal artery using a 4x4 angio score balloon.Following this the origin of the anterior tibial artery was angio-plastied using a 2.5x4 cm balloon.At 8 atm the balloon ruptured and upon removal the distal balloon and radiopaque marker had sheared off in the anterior tibial artery.The balloon catheter was found to be intact.Multiple attempts were made to cross the arterial tibial artery next to the balloon to try to eat their snare or deflate balloons and pull the retained balloon into the popliteal artery.Where it could be snared.However, on every attempt the balloon fragment was being pushed farther down the anterior tibial and therefore could not be retrieved.Fda safety report id # (b)(4).

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 9489282
• Report Number: MW5091705
• Device Sequence Number: 10827849
• Product Code: DQY
• UDI-Device Identifier: 08717648156014
• UDI-Public: (01)08717648156014(17)220131(10)
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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: 01/31/2022
• Device Model Number: A2025-040
• Device Catalogue Number: CE 086
• Device Lot Number: 8082841
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 86