MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013465-040
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the tortuous iliac artery where there were stents present as well as calcium and aneurysms, via contralateral approach.The 3x40 mm armada 18 percutaneous transluminal angioplasty (pta) catheter was advanced over a command guide wire through a 6fr sheath.The armada balloon was unable to be advanced to the lesion and was also unable to be removed from the guide wire.The devices were removed together and the command guide wire was attempted to be re-advanced; however, it was not possible to recross the lesion and the procedure was aborted.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.The patient will come back for another procedure, attempting antegrade approach.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.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported difficulty advancing and removing the guide wire from the device could not be confirmed.Production record and corrective and preventive actions (capa) reviews were 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.The investigation was unable to determine a conclusive cause for the reported complaints.However, possible factors that may contribute to the difficult advancing and removing the bdc from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, buildup of procedural contaminants in the guide wire lumen, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the shaft of the catheter.A conclusive cause for the reported complaints could not be determined since the difficulty could not be confirmed during return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 18 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19436083
• Report Number: 2024168-2024-06432
• Device Sequence Number: 20946403
• Product Code: LIT
• UDI-Device Identifier: 08717648207860
• UDI-Public: (01)08717648207860(17)261130(10)3061441
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 06/18/2024

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: 1013465-040
• Device Lot Number: 3061441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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: COMMAND GUIDE WIRE
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 70 KG