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

Model Number	A2020-040
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 information provided, a definitive cause for the reported difficulty could not be determined.Possible factors that may contribute to resistance with the guide wire may include, but are not limited to, device placement technique, introducer sheath support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.A conclusive cause for the reported complaint could not be determined since the device or component were not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the right dorsalis pedis artery.A 2x40mm armada 14 balloon dilatation catheter (bdc) was advanced over a 2x40mm non-abbott guidewire (gw) and inflated three times to 6atm; however, the gw was noted to break.The bdc was fully deflated, and during an attempt to withdraw the broken gw it was noted that the wire could not be removed through the bdc.Therefore, the device was removed as a single unit and the procedure was concluded.There were no adverse patient effects nor clinically significant delay in procedure.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, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21918177
• Report Number: 2024168-2025-04356
• Device Sequence Number: 9096452
• Product Code: DQY
• UDI-Device Identifier: 08717648155956
• UDI-Public: (01)08717648155956(11)241107(17)280430(10)4110741
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• 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): 04/28/2025

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 Model Number: A2020-040
• Device Catalogue Number: A2020-040
• Device Lot Number: 4110741
• 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: 04/07/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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: 2X40MM UNSPECIFIED GUIDEWIRE
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 66 KG