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

Catalog Number	B2120-040
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual, dimensional, functional and sem/chem analysis were performed on the returned device.The reported difficulty advancing the device over the guide wire was confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.However, a review of the complaint history of the reported lot revealed similar complaints from this lot, indicating there is a potential quality issue.Based on the evaluation of the returned device, a potential product quality issue has been identified for the reported difficulty advancing the device over the guide wire.An unknown clear material was noted in the hub guide wire port at the proximal glue port area which resulted in the reported difficulty advancing the device over the guide wire and may be related to a manufacturing issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported the procedure was to treat a moderately calcified and tortuous lesion in the thoracic aorta.The 12x40mm armada 35 balloon dilatation catheter (bdc) was advanced however it was noted the guide wire did not exit the bdc.Different guide wires were attempted however the same issue occurred therefore the bdc was removed from the anatomy.Another armada 35 of the same size and lot was opened however the same issue occurred.The procedure was completed using another armada 35.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Return device analysis of both armada devices confirmed foreign material inside the hib guide wire port at the proximal glue port area.

• 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: 19498065
• Report Number: 2024168-2024-06748
• Device Sequence Number: 7870490
• Product Code: LIT
• UDI-Device Identifier: 08717648155550
• UDI-Public: (01)08717648155550(17)261231(10)30719G2
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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
• Report Date (Section B): 06/10/2024

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 Catalogue Number: B2120-040
• Device Lot Number: 30719G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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
• Patient Sex: Unknown