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

Model Number	B1070-100
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a highly stenosed common femoral artery (cfa) to prosthetic graft interposition autogenous vein graft.The 7x100mm armada balloon dilatation catheter (bdc) was used the procedure for post dilatation of a covered stent; however the balloon ruptured below rated burst pressure (rbp).The balloon was inflated just above nominal pressure one time.Fragments of the balloon embolized in the common and external iliac arteries; therefore, four covered stents were used to jail the balloon fragments.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
A visual inspection, scanning electron microscopy (sem) analysis, and review of the angiographic images was performed.The reported material rupture and material separation was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Sem analysis was performed to further analyze the material rupture.The results determined that the proximal balloon separation may be attributed to mechanical damage to the outer surface.Multiple areas of mechanical damage and tearing were documented at and adjacent to the separated edge of the balloon.As the distal half of the separation was not submitted, it could not be determined whether the rupture extended in the longitudinal direction or had an additional site of failure initiation.An abbott vascular medical affairs expert reviewed the details of the case and the angiographic images that were provided from the account.The provided media (angio jpeg images) partially confirms the malfunction described in the complaint summary.The 7x100mm armada balloon catheter used for post dilatation of a covered stent ruptured and fragments of balloon embolized.The results indicated that a probable cause cannot be determined from the provided media.Based on the reported information and the observations from the returned analysis, the reported difficulties appear to be related to circumstances of the procedure.There was no leak noted during preparation, suggesting that the damage was not pre-existing.In this case, it is likely that the surface of the balloon material became damaged due to interaction with the covered stent and/or the highly stenosed lesion resulting in the noted mechanical damage and caused the balloon to rupture during inflation.The material separation resulting in embolization and unexpected medical intervention to embed the separated balloon fragments with four covered stents was likely due to the ruptured balloon material catching on the covered stent or highly stenosed lesion during withdrawal resulting in separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 correction: medical device problem code 1562 added.

• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20570569
• Report Number: 2024168-2024-12750
• Device Sequence Number: 8095245
• Product Code: LIT
• UDI-Device Identifier: 08717648154812
• UDI-Public: (01)08717648154812(17)260731(10)30203G1
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: B1070-100
• Device Catalogue Number: B1070-100
• Device Lot Number: 30203G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 45 KG