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

Model Number	B1070-060
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 7x60mm armada 35 balloon dilatation catheter, when flushing a leak was noted on the side of the balloon.There was a hole in the balloon.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.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported inflation issue could not be confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported inflation issue could not be determined.Possible factors that may contribute to difficulty inflating may include, but are not limited to, poor connection with the inflation device, insufficient preparation, inflation technique, patient anatomical morphology, and patient disease state.In this case, a conclusive cause cannot be determined since the reported complaint could not be confirmed during return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction to h6 - adverse event problem; medical device problem codes 1354 & 4008 removed.
Event or Problem Description
Subsequent to the initial report being filed, the following additional information was provided.It was reported that the procedure was to treat the superficial femoral artery (sfa).The 7x60mm armada 35 balloon dilatation catheter was advanced to the target lesion without issue.However, the balloon failed to inflate.Therefore, a leak or hole in the balloon was suspected, but not observed as initially reported.There was no adverse patient effect.No additional information was provided.

• 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: 23996881
• Report Number: 2024168-2026-00141
• Device Sequence Number: 10523810
• Product Code: LIT
• UDI-Device Identifier: 08717648154799
• UDI-Public: (01)08717648154799(17)290228(10)50910G1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: B1070-060
• Device Catalogue Number: B1070-060
• Device Lot Number: 50910G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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