MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2030-120
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.User facility medwatch report (b)(4).
Event or Problem Description
User facility medwatch report received stating: armada 14 pta catheter used during the surgical procedure (left lower extremity angiogram/angioplasty) and the hi torque command es guide wire was pushed through the catheter in the appropriate manner, and on xray noticed the wire pushed through the balloon on the end of the catheter.Catheter and the guidewire immediately withdrawn and found the guide wire protruding through the balloon.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported tear/hole in the inner member within the balloon was 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 identified no other similar complaints reported from this lot.The investigation was unable to determine a definitive cause for the reported difficulties.However, based on the reported information and evaluation of the returned product, it may be possible that while advancing the ht command from the proximal end of the armada 14, the balloon may have been bent in the anatomy causing the distal end of the wire to puncture through the inner member and prolapse within the balloon.There were no leaks noted during preparation, suggesting that the damage to the inner member was not pre-existing and likely occurred during use.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
User facility medwatch report (0504240000-2022-8050) received stating: armada 14 pta catheter used during the surgical procedure (left lower extremity angiogram/angioplasty) and the hi torque command es guide wire was pushed through the catheter in the appropriate manner, and on xray noticed the wire pushed through the balloon on the end of the catheter.Catheter and the guidewire immediately withdrawn and found the guide wire protruding through the balloon.Subsequent to the initially filed report, the following information was provided: it was reported that the procedure was to treat a lesion in the posterior tibial artery with 80% stenosis and heavy calcification.It was noted the guidewire curled inside the balloon.The guidewire and catheter were removed together.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 14 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: 16179104
• Report Number: 2024168-2023-00557
• Device Sequence Number: 2633813
• Product Code: DQY
• UDI-Device Identifier: 08717648156106
• UDI-Public: 08717648156106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: 07/31/2024
• Device Model Number: A2030-120
• Device Catalogue Number: A2030-120
• Device Lot Number: 1022441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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: HT COMMAND ES 300CM.
• Patient Age: 79 YR
• Patient Sex: Unknown