MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	B2070-120
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational context.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaints appear to be related to operational context.There was no leak noted to the balloon during preparation or during the first two inflations, which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the balloon dilatation catheter (bdc) interacted with the heavily calcified anatomy resulting in the reported difficulty advancing the device and subsequently the balloon ruptured during the second inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional devices referenced in b5 are filed under separate medwatch numbers.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right superficial femoral artery (sfa).The 018 command st guide wire (gw) was advanced through a 6ffsheath via left groin access, up and over into right leg.During advancement, resistance was noted throughout the whole vessel due to calcium.The vessel was pre-treated twice with laser atherectomy.Following this, a 6.0x200mm armada 18 balloon dilatation catheter (bdc) was advanced with resistance and inflated it to 14 atms, five times, for 20 seconds each time.The decision was made to re-treat the lesion with the laser atherectomy.The armada 18 bdc was removed, and the laser atherectomy was performed.The armada 18 bdc was reinserted back into the lesion and inflated 9 times at 14 atms for 20 seconds; however, the balloon ruptured.The bdc was removed and a 7x120mm armada 35 bdc was advanced with resistance due to calcium and positioned more proximal in the sfa.The armada 35 was inflated for 30 seconds at 10 atms, then inflated again to 10 atms for 10 seconds; however, the balloon ruptured on the second inflation.The bdc was removed, and two more passes were performed with the laser atherectomy device.A 7.0x120mm armada 35 bdc was advanced with resistance and inflated once to 10 atms for 30 seconds, a second time to 10 atms for 30 seconds, and then inflated a third time to 10 atms for 34 seconds but ruptured.The bdc was removed and a 6x40 mm non-abbott bdc was used.Next, a 6x150mm supera self expanding stent (ses) was implanted distally in popliteal/sfa.Then, a 6.5x120mm supera ses was implanted proximally in the sfa.Pseudoaneurysms were identified in a different area from which the supera stents were implanted and were treated with a 7x58mm and a 7x50mm non-abbott stent.Post dilatation was performed with a new 6x200mm armada 18 balloon and the procedure was concluded.In the physicians opinion, the supera stents did not cause or contribute to the pseudoaneurysms.There were no adverse patient sequela nor clinical delay.No additional information was provided.

• Brand Name: ARMADA
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22365429
• Report Number: 2024168-2025-06721
• Device Sequence Number: 21186715
• Product Code: LIT
• UDI-Device Identifier: 08717648155390
• UDI-Public: (01)08717648155390(17)260930(10)30425G1
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: 09/30/2026
• Device Model Number: B2070-120
• Device Catalogue Number: B2070-120
• Device Lot Number: 30425G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White