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

Model Number	A2030-120
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the mildly calcified anterior tibial artery with the 3.0x120mm armada 14 percutaneous transluminal angioplasty (pta) catheter.The balloon was advanced with no resistance and inflated once to 4 atmospheres and ruptured.A same size balloon was used to complete the procedure.There were no adverse patient effects and no clinically significant delay.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture was confirmed.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 that the reported balloon rupture appears 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.Return device analysis noted pinholes in the balloon, proximal to the distal marker, with multiple pinholes at the proximal end of the balloon, and distal to the proximal marker.There were also scratches and lifted material near the ruptures.In this case, it is likely that the balloon interacted with an accessory device after preparation and/or during advancement such that the balloon became damaged and subsequently gave the impression of a balloon rupture during attempts to inflate it.Based on the reported information, 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19625876
• Report Number: 2024168-2024-07717
• Device Sequence Number: 8121275
• Product Code: DQY
• UDI-Device Identifier: 08717648156106
• UDI-Public: (01)08717648156106(17)270331(10)3102441
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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 Model Number: A2030-120
• Device Catalogue Number: A2030-120
• Device Lot Number: 3102441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American