MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B2050-120
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code 2017 incorrect removal the device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous lesion in the superficial femoral artery (sfa).A 5x120mm/135cm armada 35 balloon dilatation catheter (bdc) was slow during inflation; however, it was used for dilatation of the lesion.After dilatation, the balloon deflated slow and incomplete, despite 10 to 20 attempts to deflate, holding negative for 10 to 60 seconds for each deflation attempt.The syringe was changed but only a small volume could be sucked out of the balloon by manually pulling hard on the syringe so that it would fit through the sheath.There was no reported adverse patient effect and no clinically significant delays in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported inflation and deflation issues could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported by the account that the balloon was removed partially inflated.It should be noted the percutaneous transluminal angioplasty catheter (pta), armada 35 / armada 35 ll, global, instruction for use (ifu) states: deflate the balloon by aspirating the inflation syringe or inflation device.Maintaining a vacuum in the balloon, withdraw the catheter.In this case, it is likely that the ifu violation did not contribute to the reported complaint and had to happen given the clinical situation.The investigation was unable to determine a conclusive cause for the reported inflation and deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 16430922
• Report Number: 2024168-2023-01843
• Device Sequence Number: 16799767
• Product Code: LIT
• UDI-Device Identifier: 08717648155215
• UDI-Public: 08717648155215
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/27/2023

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: 07/31/2025
• Device Model Number: B2050-120
• Device Catalogue Number: B2050-120
• Device Lot Number: 20209G1
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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