MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	B1070-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
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 performed to treat a heavily calcified and mildly tortuous lesion in the left common femoral artery.The 7x40mm armada 35 balloon dilatation catheter (bdc) was attempted to be inflated; however, the balloon was noted to rupture under the rated burst pressure.During removal, resistance was felt with the 6fr sheath and the balloon was noted to separate in the anatomy.A non-abbott stent was deployed to embed the separate balloon portion to the vessel wall.There were no adverse patient sequela nor clinical delay no additional information was provided.
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 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 by the account that upon removal of the dilatation catheter, resistance was noted, and force was applied.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use states: maintaining a vacuum in the balloon, withdraw the catheter.Note: gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as one unit.In this case, the physician did not follow the instructions for use.Instead of using gentle counterclockwise twisting motion to remove the device, force was applied which likely contributed to the reported separation.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported balloon rupture, difficulty removing the device, unexpected medical intervention and device embedded in tissue or plaque appear to be related to operational context.The reported separation appears to be related to use error/operational context as it is likely that the ifu violation of applying excessive force likely did contribute to the separation.There was no leak noted to the balloon 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 calcified anatomy resulting in the reported balloon rupture during inflation.In addition, it is likely that the ruptured balloon material became stuck on the introducer sheath, resulting in the reported difficulty removing the device and ultimately lead to the reported balloon separation, as force was applied.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: PERIPHERAL DILATATION CATHETER
• 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: 22500619
• Report Number: 2024168-2025-07229
• Device Sequence Number: 12519925
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: (01)08717648154782(17)280630(10)50110G1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 50110G1
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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: SHEATH: 6FR 45CM SCOOK HEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown