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

Model Number	B1050-040
Medical Device Problem Codes	Inflation Problem (1310); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported inflation issue 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.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported inflation issue and noted tear/hole in the shaft could not be determined.There was no leak noted during preparation and the account confirmed the bdc was prepared per the ifu, which suggests a product quality issue did not contribute to the reported difficulty.Return device analysis noted a tear/hole in the shaft proximal to the proximal seal.In this case, it is possible that the device was inadvertently mishandled during preparation and/or interacted with an accessory device, such that it became damaged (noted tear/hole) resulting in the reported inflation issue; however, this cannot be confirmed.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the arteriovenous fistula stenosis with moderate calcification, mild tortuosity and 70% stenosis.The 5x40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion and inflated to 2 atmospheres on the first inflation; however, the pressure of the balloon would not continue to increase and the balloon partially inflated.Another same size device was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that there was a tear/hole on the top and bottom of the inner and outer members.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: 20747190
• Report Number: 2024168-2024-13808
• Device Sequence Number: 8648864
• Product Code: LIT
• UDI-Device Identifier: 08717648154607
• UDI-Public: (01)08717648154607(17)271130(10)40605G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/21/2024

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: B1050-040
• Device Catalogue Number: B1050-040
• Device Lot Number: 40605G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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
• Patient Sex: Unknown