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

Model Number	F2020-020
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.D4: the udi is not known as the part and lot number were not provided.
Event or Problem Description
It was reported that the procedure performed was to treat a moderately calcified, right popliteal artery.The 2.0x20 armada 14 xt balloon dilatation catheter (bdc) was advanced over the ht command 14 es guide wire through a 5f catheter.When removing the guide wire for angiogram, resistance was noted.A failed attempt to re-advance was made and the guide wire got stuck distally.The armada 14 bdc was removed and appeared twisted with irregular points.The armada 14 bdc was straightened and able to cross the lesion; however, the same issue occurred and the ht command guide wire seemed to prematurely exit the catheter.The bdc and guide wire were removed.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
D1 correction: brand name updated.D2 correction: common device name, procode updated.D4 correction: model, catalog, lot number, expiration date updated.G4 correction: pma/510(k) number updated.H4 correction: device manufacture date added.
Event or Problem Description
Subsequent to the previously filed report, additional information was provided: the 2.0x20 armada 14 xt balloon dilatation catheter (bdc) was advanced over the ht command 14 es guide wire through a 5f catheter.Upon removal of the guidewire, resistance was noted due to the bdc.During re-advancement of the guidewire, resistance was noted due to the armada and the guide wire got stuck distally.The armada 14 bdc was removed, and the shaft was twisted.The armada 14 bdc was straightened and able to cross the lesion; however, the same issue occurred, and the ht command guide wire seemed to prematurely exit the catheter.The bdc and guidewire were removed.A new armada 14 xt over the same ht command 14 es guidewire, was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the previously filed report, returned device analysis observed that the inner and outer member of the armada 14 bdc was stretched.It was noted that prior to removing the guide wire, the armada 14 xt over the ht command 14 es guide wire and lesion easily.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported shaft damage (stretched, kinked and bunched) was confirmed.The reported difficulty advancing and removing the device from the guide wire could not be replicated in a testing environment due to the condition of the returned device.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.It was reported that the shaft was noted to be twisted and was straightened out and attempted to be used again.It should be noted the percutaneous transluminal angioplasty (pta) catheter, armada 14 xt, over the wire (otw), global, instruction for use (ifu) states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.Instead, prepare a new catheter.In this case, it is unlikely that the reported ifu violation contributed to the reported complaint.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaints appear to be related to circumstances of the procedure.There were no damages noted to the armada 14 xt or the ht command 14 es guide wire during inspection prior to use or during preparation, which suggests a product quality issue did not contribute to the reported difficulties.Return device analysis noted the inner and outer member was stretched, kinked and bunched sporadically.In this case, it is likely that the device was inadvertently repositioned and/or mishandled during initial use, such that the shaft stretched, kinked and bunched, resulting in the reported damage and subsequently the reported difficulty removing and readvancing the device in the guide wire.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 - use after damage.

• 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 PR UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23819348
• Report Number: 2024168-2025-12085
• Device Sequence Number: 10067136
• Product Code: LIT
• UDI-Device Identifier: 08717648182938
• UDI-Public: (01)08717648182938(11)250616(17)280531(10)50616G1
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: F2020-020
• Device Catalogue Number: F2020-020
• Device Lot Number: 50616G1
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 02/19/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/15/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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: HT COMMAND ES 14.
• Patient Sex: Unknown