MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	F2012-012
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
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 complaints could not be determined.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.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 deflation issue and difficulty removing the device from the guide wire 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 and tortuous lesion in the anterior tibial artery.A 1.2x12mm armada 14 xt balloon dilatation catheter (bdc) was prepared with no noted issues and dilated, once, to 6atms; however, when the physician attempted to deflate the balloon, it was noted to not deflate properly.Additionally, the bdc became stuck on the guide wire.After being held at negative pressure for 50 seconds the balloon was able to deflate and the bdc was removed, and a new armada 14 bdc was used and the procedure was continued.There were no adverse patient effects nor clinical delay reported.No additional information was provided.

• Brand Name: ARMADA
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 22778079
• Report Number: 2024168-2025-08325
• Device Sequence Number: 9167377
• Product Code: LIT
• UDI-Device Identifier: 08717648182815
• UDI-Public: (01)08717648182815(11)220912(17)250831(10)20912G2
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K121352
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: 08/31/2025
• Device Model Number: F2012-012
• Device Catalogue Number: F2012-012
• Device Lot Number: 20912G2
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown