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

Model Number	B1050-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left superficial femoral artery (sfa) with moderate calcification and 70% stenosis.The 5x60 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was inflated 3 times to 20 atmospheres and the balloon did not achieve indentation of the vessel and ruptured.An attempt was made to pull the balloon back into the guiding sheath but the distal marker caught at the sheath tip.While attempting further retrieval against strong resistance, the device separated near the distal marker.With the guide wire left in place the sheath was upsized to 8fr and retrieval was attempted using the sheath to cover the separated balloon but this was unsuccessful.Subsequently a snare was used to hold the tip of an 035 guide wire and pull it into the sheath, however this was unsuccessful and the snare ended up fracturing.Ultimately the entire system was removed.The separated balloon migrated into the distal femoral artery and could not be recovered so it was left in the anatomy.Angiography confirmed flow.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
Visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty removing the device and patient-device incompatibility could not be replicated in a testing environment as it was based on operational circumstances.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 that the reported patient-device incompatibility, balloon rupture, difficulty removing the device, unexpected medical intervention and foreign body in patient appear to be related to operational context.The reported separation appears to be related to user error/operational context.In this case, it is likely that the instructions for use (ifu) violation contributed to the reported separation.Based on the reported case information, device selection in conjunction with challenging lesion characteristics, likely contributed to the reported difficulties, as the armada balloon likely conformed to the blockage as designed and did not fully resolve the issue in the lesion.Additionally, there was no leak noted to the balloon during preparation or during the first three inflations of the balloon, 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 moderately calcified anatomy such that the balloon became damaged and subsequently ruptured during the last inflation.Subsequently, it is likely that the ruptured balloon material became caught on the sheath, resulting in the reported difficulty removing the device and, upon applied force, the balloon ultimately separated.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: medical device problem code 2017 excessive force.
Event or Problem Description
Subsquent to the initially filed report it was reported that there was no hospitalization and there was no report of postoperative worsening.The patient improved as scheduled.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: 24073036
• Report Number: 2024168-2026-00265
• Device Sequence Number: 15763142
• Product Code: LIT
• UDI-Device Identifier: 08717648154614
• UDI-Public: (01)08717648154614(17)260731(10)30217G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/17/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: B1050-060
• Device Catalogue Number: B1050-060
• Device Lot Number: 30217G1
• 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: 12/25/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic