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

Model Number	B2050-100
Medical Device Problem Codes	Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017- failure to follow steps / instructions.
Event or Problem Description
It was reported that the procedure was performed to treat the superficial femoral artery with mild tortuosity, mild calcification and 90% stenosis.The 5.0x100mm armada 35 percutaneous transluminal angioplasty (pta) catheter was not prepped per ifu and advanced over an unspecified 0.035 guide wire.The balloon was attempted to be inflated yet the balloon did not inflate as confirmed by angiogram.A non-abbott 5x100mm balloon was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis identified that the device leaked from the hub during testing.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed mdr report: it was reported that a new unspecified 0.035 guide wire was used for the procedure.The gw was introduced into the guidewire port and the back end was used.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing, and sem analysis 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.It was reported that the device was not prepared (air aspiration) outside the anatomy.It should be noted that the percutaneous transluminal angioplasty (pta) armada 35 / armada 35 ll, global, instruction for use indicates to perform the steps to remove all air and verify the integrity of the pta catheter.Leave the catheter under negative pressure until the balloon is at the target lesion site.Then the device can be introduced the device into the vascular system.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the leakage at the proximal end of the luer, at the guidewire port, may be attributed to mechanical damage.The leak area was on the outer surface of the guidewire lumen, near the opening of the inflation lumen of the dual lumen shaft.Mechanical damage was documented at the leak edge.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported inflation issue could not be determined.Sem analysis determined the leakage at the proximal end of the luer, at the guidewire port, may be attributed to mechanical damage.Mechanical damage was documented at the leak edge.In this case, it is possible that the noted damage resulted from interaction with the guide wire during loading and/or inadvertent manipulation of the guide wire in the device; however, a conclusive cause cannot be determined.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: 20616058
• Report Number: 2024168-2024-12970
• Device Sequence Number: 8874497
• Product Code: LIT
• UDI-Device Identifier: 08717648155208
• UDI-Public: (01)08717648155208(17)270131(10)30801G1
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/29/2024

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: B2050-100
• Device Catalogue Number: B2050-100
• Device Lot Number: 30801G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED 0.035 GUIDE WIRE
• Patient Sex: Unknown