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

Model Number	B2050-150
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The 5x150mm armada 35 balloon dilatation catheter (bdc) was observed that the balloon was punctured during initial preparation.There was no patient involvement and no clinically significant delay reported in the procedure.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
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.It was reported by the account that the balloon was inflated before entering the patient anatomy.It should be noted that the percutaneous transluminal angioplasty (pta), armada 35 / armada 35 ll, global, information for use (ifu) states, to perform steps 1-7 to prepare the catheter and under step 7 it states, to leave the catheter under negative pressure until the balloon is at the target lesion site.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.Based on the information provided, a definitive cause for the reported balloon rupture could not be determined.Possible factors that could contribute to the reported balloon rupture, include, but are not limited to, balloon damage during processing of the balloon material, insufficient preparation, inflation technique, or inadvertently mishandled during preparation.In this case, a conclusive cause for the reported complaint could not be determined since the device was not returned for analysis.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 yes to not returning h6 correction: device code 4008 removed.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the balloon was inflated prior to been loaded on to the guide wire or entering a patient when the balloon punctured.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: 20500257
• Report Number: 2024168-2024-12368
• Device Sequence Number: 7228196
• Product Code: LIT
• UDI-Device Identifier: 08717648155222
• UDI-Public: (01)08717648155222(17)261130(10)30626G1
• 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): 01/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: B2050-150
• Device Catalogue Number: B2050-150
• Device Lot Number: 30626G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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 Sex: Unknown