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

Model Number	B1040-060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 4.0x60mm armada 35 balloon dilatation catheter (bdc), the device was noted to have a leak due to air not going all throughout the balloon.When trying to prep the balloon by sucking back on the balloon hub with the syringe, it constantly pulled air into the syringe.Tried multiple times including re-preparation but unsuccessful.Another same size armada 35 balloon was used to complete the procedure.There was no device use or patient involvement.There was 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 and functional inspections were performed on the returned device.The reported leak was not 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 of the reported lot revealed no other complaints reported from this lot.The investigation was unable to confirm the reported leak during functional testing of the returned unit.It may be possible that there was a faulty connection with the syringe or inflation device, resulting in the continuous air bubbles during preparation; however, this could not be confirmed.There is no indication of a product quality issue with respect 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: 17199841
• Report Number: 2024168-2023-06739
• Device Sequence Number: 5684415
• Product Code: LIT
• UDI-Device Identifier: 08717648154522
• UDI-Public: 08717648154522
• 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): 08/10/2023

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: 04/30/2025
• Device Model Number: B1040-060
• Device Catalogue Number: B1040-060
• Device Lot Number: 11130G1
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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