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

Model Number	A2020-200
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the anterior tibial artery which was mostly occluded.A non-abbott 4fr sheath was used and a command guide wire was advanced to the lesion.The 2.0x200 mm armada 14 percutaneous transluminal angioplasty (pta) catheter would not advance because the guide wire could not advance through the device.A guide wire from another manufacturer was used but still the balloon would not advance and it seemed to be "stinking" [sticking] to the guide wire.Contrast also would not go through the armada pta catheter.A larger unspecified balloon was used to complete the procedure.There were no adverse patient effects and 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.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
Subsequent to the initially filed report it was reported a non-abbott balloon was used to advance over the wire from another manufacturer to complete the procedure.The armada had advancement issues and 'stinking' with both wires.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing and dimensional analysis were performed on the returned device.The reporter failure to advance, difficulty advancing and removing the device could not be confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported issue could not be determined.Potential factors that could contribute to failure to advance include, but are not limited to, pre-dilatation strategy, device placement technique, and accessory device support.Additionally, possible factors that may contribute to the difficult advancing and removing the balloon dilatation catheter (bdc) from the guide wire causing resistance between the devices may include, but not limited to, device placement technique, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.In this case, a conclusive cause for the reported complaints could not be determined since the complaints could not be confirmed during return analysis.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.B5: describe event or problem: updated.

• 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20238792
• Report Number: 2024168-2024-10969
• Device Sequence Number: 15582707
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: (01)08717648155994(17)250430(10)1110841
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Expiration Date: 04/30/2025
• Device Model Number: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 1110841
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND GUIDE WIRE; VIPER WIRE
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White