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

Model Number	B1080-040
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2024
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 8.0x40mm armada 35 balloon dilatation catheter (bdc) ruptured when it was inflated due to the calcification; however, did not fully deflate.During removal of the bdc resistance was felt with the unspecified introducer the balloon distal marker ruptured [separated].An attempt was also made to remove the unspecified guide; however, it was stuck with the introducer as both were removed together up to the axillary level.Another.035 non-abbott guide was advanced in parallel in the introducer to not lose the aortic catheterization and attempt to remove the entire first guide, introducer and distal separated marker from the balloon; however, was unsuccessful as the balloon remain stuck in the axillary arterial wall.The introducer was removed alone and snaring device was advanced over the.035 non-abbott guide wire in an attempt to snare the initial guide wire and distal balloon marker; however, was unsuccessful.The balloon marker remained stuck in anatomy.There was no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported complaints, unexpected medical intervention and foreign body in patient appear 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 difficulty.In this case, it was reported by the account that the balloon interacted with the patient calcified anatomy such that the balloon became damaged, ruptured during inflation and subsequently the balloon did not fully deflate.In addition, the difficulty reported during removal and separation of the balloon were likely the result of the ruptured balloon material catching on the introducer sheath and anatomy during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 correction: device available for evaluation updated from returning to not returning.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported deflation issue, difficulty removing the device from the introducer sheath and balloon rupture could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the device from the anatomy 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.Based on the information received, the investigation determined that the reported balloon rupture, deflation issue, difficulty removing the device, separation, unexpected medical intervention and foreign body in patient appear 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 difficulty.In this case, it was reported that the balloon interacted with the heavily calcified anatomy such that the balloon ruptured during inflation and subsequently the balloon did not fully deflate.In addition, the difficulty reported during removal and separation of the balloon were likely the result of the ruptured balloon material catching on the introducer sheath and anatomy during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.E1 correction: physician name and title updated.H6 correction: type of investigation code 4114 removed.
Event or Problem Description
Subsequently, after the previous report was filed it was reported that the procedure was to treat a heavily calcified common left iliac artery.It was confirmed that the distal marker did separate from the armada 35 and was found in the subcutaneous tissue in the extravascular after arteriography was performed.No additional information was provided.

• 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: 21256433
• Report Number: 2024168-2025-00961
• Device Sequence Number: 12781221
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: (01)08717648154867(17)271231(10)40723G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 03/05/2025

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 Model Number: B1080-040
• Device Catalogue Number: B1080-040
• Device Lot Number: 40723G1
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 03/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/06/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown