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

Model Number	B2040-040
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery (sfa) with moderate calcification, moderate tortuosity and 80% stenosis.The 4x40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced and inflated; however, it was seen the balloon only partially inflated and the device was losing pressure.It was noted there was a leak at the hub of the device.The balloon was removed and a new armada pta catheter was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 leak and inflation issue could not be determined.Possible factors that may contribute to a leak include, but are not limited to, manufacturing, damage to the sidearm/inflation lumen, damage to the balloon or loose connections.In this case, it may be possible that the sidearm and or inflation port within the sidearm was damaged; however, without having the device to examine, a conclusive cause could not be determined.Furthermore, it is likely that the leak contributed to the reported inflation issue; however, it is unknown what caused the leak, therefore, a conclusive cause for the leak or inflation issue cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9: corrected device returning from yes to no.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported complaints could not be confirmed.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, a definitive cause for the reported complaints could not be determined.In this case, it is possible that the inflation device did not form a secure connection with the armada 35 device giving the impression of a leak and subsequently an inflation issue; however, a conclusive cause cannot be determined since the complaints could not be confirmed during return analysis and the inflation device was not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9: corrected device available for evaluation from no to yes.H6: corrected type of investigation code 4114 was removed.H6: correction investigation findings code 3221 was removed.H6: correction investigation conclusions code 4315.H11: additional mfg narrative: revised.

• 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: 22569032
• Report Number: 2024168-2025-07573
• Device Sequence Number: 3993965
• Product Code: LIT
• UDI-Device Identifier: 08717648155086
• UDI-Public: (01)08717648155086(17)271130(10)40617G1
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2025

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: B2040-040
• Device Catalogue Number: B2040-040
• Device Lot Number: 40617G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/22/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/15/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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
• Patient Sex: Unknown