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

Model Number	B2090-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production record and corrective and preventative actions (capa) 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.It was reported by the account that upon withdrawal of the dilatation catheter, resistance was noted, and force was applied.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instructions for use (ifu), states: maintaining a vacuum in the balloon, withdraw the catheter.Note: gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as one unit.In this case, the physician did not follow the instructions for use.Instead of using gentle counterclockwise twisting motion to remove the device, force was applied which likely contributed to the reported separation.Based on the information received, the investigation determined that the reported balloon rupture, difficulty removing the device, and surgical intervention appear to be related to operational context; however, the reported separation appears to be related to use error/operational context.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the heavily calcified anatomy such that the balloon became damaged and ruptured.In addition, the ruptured balloon material likely interacted with the introducer sheath during removal, resulting in the reported difficulty removing the device and upon further manipulation and applied force, the device ultimately separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 - medical device problem code: 2017 - excessive force.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the common femoral artery.After a stent was deployed, a 9x40mm armada 35 balloon dilatation catheter (bdc) was attempted to be used for post-dilatation; however, the balloon was noted to burst at 8atms and during withdrawal resistance was felt with the 6f introducer sheath after the bdc was fully deflated, subsequently causing the balloon and tip of the bdc to be torn off from the delivery system.Arteriotomy was performed and the balloon material and its tip were removed, and the artery was sutured with a vascular suture completing the procedure.There was no adverse patient sequela reported 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: 21658082
• Report Number: 2024168-2025-02950
• Device Sequence Number: 8431384
• Product Code: LIT
• UDI-Device Identifier: 08717648155475
• UDI-Public: (01)08717648155475(17)260630(10)30104G1
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: B2090-040
• Device Catalogue Number: B2090-040
• Device Lot Number: 30104G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6F.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female