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

Model Number	B1060-060
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the common femoral artery (cfa) with heavy calcification and heavy tortuosity.The 6.0x60mm armada 35 balloon dilatation catheter (bdc) had resistance during advancement with the anatomy and ruptured during the first inflation before reaching nominal pressure.The device was prepared per instructions for use (ifu).Another abbott balloon, jade, was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture was 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, the investigation determined that the reported balloon rupture appears to be related to 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 tortuous and heavily calcified anatomy resulting in the reported balloon rupture during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Additional Manufacturer Narrative
Correction h11- additional mfr narrative updated.Visual inspection and scanning electron microscopy (sem) analysis were performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational context.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.The investigation determined the reported difficulty advancing the device appears to be related to operational context; however, a conclusive cause for the reported balloon rupture could not be determined.It was reported that the bdc interacted with the heavily tortuous and heavily calcification anatomy resulting in the reported difficulty advancing the device.Although sem analysis indicates the rupture may be attributed to material/processing discrepancy, per manufacturing engineering, there is no indication of material bad performance along the different manufactured lots.Per manufacturing engineering, possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, interactions with other devices or patient anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 23550291
• Report Number: 2024168-2025-11523
• Device Sequence Number: 9682970
• Product Code: LIT
• UDI-Device Identifier: 08717648154706
• UDI-Public: (01)08717648154706(17)281130(10)50620G1
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: B1060-060
• Device Catalogue Number: B1060-060
• Device Lot Number: 50620G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 02/19/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/13/2025; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 114 KG