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	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional ht command 14 device referenced in this report is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The 3.0x120mm armada 14 balloon dilatation catheter (bdc) was positioned and as the physician wanted to change the guidewire, the hi-torque (ht) command 14 guidewire went into the wrong balloon lumen [tear to armada 14 balloon].The armada 14 balloon and ht command 14 guidewire had to be removed.A new armada and guidewire were used to complete the procedure.There was no adverse patient effect or clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and scanning electron microscopy (sem) 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 backloading the armada 14 over the first guide wire, the proximal end of the wire may have inadvertently punctured the inner lumen within the balloon.Additionally, when the guide wire was exchanged for the ht command, as the wire was being advanced through the proximal end of the catheter, the tip of the wire found its way into the existing puncture and ended up in the balloon.The knot observed in the wire tip may have occurred due to the wire curling up on itself within the balloon creating a knot.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The 3.0x120mm armada 14 balloon dilatation catheter (bdc) was positioned and as the physician wanted to change the guidewire, the hi-torque (ht) command 14 guidewire went into the wrong balloon lumen [tear to armada 14 balloon].The armada 14 balloon and ht command 14 guide wire had to be removed.A new device was used to complete the procedure.There was no reported adverse patient effect or clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the guide wire was correctly introduced in the proximal end of the catheter but approximately near the proximal marker of the balloon, the guide wire went into the balloon.The balloon was never inflated when the wire went in the balloon.A new armada and guide wire were used to complete the procedure.There was no adverse patient effect.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: 15473341
• Report Number: 2024168-2022-09962
• Device Sequence Number: 19541258
• Product Code: DQY
• UDI-Device Identifier: 08717648156106
• UDI-Public: 08717648156106
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 09/30/2023
• Device Model Number: A2030-120
• Device Catalogue Number: A2030-120
• Device Lot Number: 0040741
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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 14 GUIDEWIRE
• Patient Sex: Unknown