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

Model Number	B2120-020
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	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis was 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 circumstances.The production record and corrective and preventive 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 and balloon rupture 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 difficulties.It was reported that the bdc interacted with the moderately calcified and moderately tortuous anatomy resulting in the difficulty advancing the device.The balloon likely interacted with the challenging anatomy, resulting in the ruptured during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Corrections: d1 ¿ brand name: updated.D3 ¿ name, address 1, city, postal code: updated.
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 lesion in the proximal third of the brachiocephalic vein with moderate calcification, moderate tortuosity and 80% stenosis.The 12x20mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced with some resistance noted, related to tortuosity close to the stenotic area.The armada was inflated once to 8 atmospheres when a rupture occurred.There was no adverse patient effects and no clinically significant delay in the procedure.Another armada balloon was used to complete the procedure.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: 19222846
• Report Number: 2024168-2024-05333
• Device Sequence Number: 7016944
• Product Code: LIT
• UDI-Device Identifier: 08717648155543
• UDI-Public: (01)08717648155543(17)260531(10)21213G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/18/2024

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 Expiration Date: 05/31/2026
• Device Model Number: B2120-020
• Device Catalogue Number: B2120-020
• Device Lot Number: 21213G1
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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: UNSPECIFIED INDEFLATOR
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 63 KG