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

Model Number	B1080-060
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
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.Attachment: medwatch report.
Event or Problem Description
User facility medwatch report (mw5161097) received that states: doctor was inflating a percutaneous transluminal angioplasty (pta) catheter.At this time, the pta catheter was already inserted in the patient's left arm.As he inflated the balloon under fluoroscopy, he immediately recognized that the balloon burst, and the distal end of the catheter was broken off.He removed the catheter that was still intact and used fluoroscopy to guide him in the removal of the detached balloon.All contents of the catheter were quickly removed from inside the patient and was confirmed with fluoroscopy.
Additional Manufacturer Narrative
Analysis was performed on the returned device.The reported needle to cuff miss was confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.The reported difficulty and subsequent treatment appear to be related to operational context.It is likely that an interaction of the device with patient anatomy or inability to maintain position/stability of the device during deployment due to circumstances of the procedure.Based on the information reviewed, 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 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: 20868641
• Report Number: 2024168-2024-14365
• Device Sequence Number: 8491280
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: (01)08717648154874(17)270930(10)40426G1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: B1080-060
• Device Catalogue Number: B1080-060
• Device Lot Number: 40426G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 59 KG