MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	B1050-080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 5.0x80mm armada 35 balloon dilatation catheter (bdc) during attempted aspiration, continuous bubbles were noted coming into the inflation device.The bdc was not used and replaced with another balloon catheter to complete the procedure.There was no patient involvement and no clinically significant delay 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.D4- the udi is not known as the part and lot number were not provided.
Additional Manufacturer Narrative
Visual inspection, functional testing, and scanning electron microscopy (sem) were performed on the returned device.The reported leak was confirmed.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.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the sample was documented as per customer request at the distal and proximal seals, luer bond areas and end of the inflation port.Radial cross sections through the luer revealed areas which suggest a gap may be present in the adhesive bond to the dual lumen.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported leak appears to be related to operational context.There was no damage noted to the balloon dilatation catheter (bdc) during inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.Return device analysis noted there was deformed material at the threads of the inflation port on hub.In this case, it is likely that the inflation device was over torqued during attempts to connect to the hub of the device, resulting in the noted damage to the threads of the hub and subsequently the reported leak.D4: part and lot number updated.

• Brand Name: ARMADA¿
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21605973
• Report Number: 2024168-2025-02654
• Device Sequence Number: 18508486
• Product Code: LIT
• UDI-Device Identifier: 08717648154621
• UDI-Public: (01)08717648154621(17)260731(10)30213G2
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/17/2025

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 Expiration Date: 07/31/2026
• Device Model Number: B1050-080
• Device Catalogue Number: B1050-080
• Device Lot Number: 30213G2
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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