MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	F2012-020
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal anterior tibial artery with heavy calcification, heavy tortuosity and 100% total occlusion.The 1.2x20 mm armada xt percutaneous transluminal angioplasty (pta) catheter became stuck with a non-abbott guide wire and both devices had to be removed from the anatomy together as a unit.The vessel access was lost and a new wire and balloon were used to complete the procedure; however, there were no reported adverse patient effects and there was no reported 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 analysis was performed on the returned device.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.The production record and corrective and preventive actions (capa) review was 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.Based on the reported information and results of the complaint investigation there is no indication the reported difficulty removing the device from the guide wire is related to a potential product quality issue.Possible factors that may contribute to the difficult removing the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.Returned device analysis noted the proximal end of the balloon and the balloon inner member were wrinkled, and the inner and outer member were sporadically bunched and wrinkled proximal to the proximal seal.In this case, it is possible that the noted wrinkled and bunched balloon, inner and outer member contributed to the noted difficulty removing the device; however, it is unknown when these damages occurred and therefore, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal anterior tibial artery with heavy calcification, heavy tortuosity and 100% total occlusion.The 1.2x20 mm armada xt percutaneous transluminal angioplasty (pta) catheter became stuck with a non-abbott guide wire and both devices had to be removed from the anatomy together as a unit.The vessel access was lost and a new wire and balloon were used to complete the procedure; however, there were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, it was reported there were no adverse patient effects and although there was a delay in the procedure, there was no harm to the patient.No additional information was provided.

• Brand Name: ARMADA
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 19567749
• Report Number: 2024168-2024-07378
• Device Sequence Number: 15001861
• Product Code: LIT
• UDI-Device Identifier: 08717648182839
• UDI-Public: (01)08717648182839(17)260930(10)31030G1
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121352
• 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): 07/26/2024
• 2 Devices were Involved in the Event: 1 2

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: 09/30/2026
• Device Model Number: F2012-020
• Device Catalogue Number: F2012-020
• Device Lot Number: 31030G1
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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: GUIDEWIRE ASAHI GLADIUS 0.014
• Patient Sex: Unknown