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

Model Number A2030-120

Device Problems Difficult to Insert (1316); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, 95% stenosed lesion in the left superior femoral artery (sfa).A 3.0x120mm/150cm armada 14 balloon dilatation catheter (bdc) was advanced to the target lesion with resistance from the anatomy.A non-abbott guide wire (gw) was then advanced to the armada, and they attempted to feed the floppy end of the gw through the armada port in order to inject contrast for imaging purposes, however, they could not insert the non-abbott guide wire into the port for unknown reasons.The armada was then inflated one time to nominal pressure of 8 atmospheres (atm), and a second time to 12 atmospheres when the balloon ruptured.The bdc was removed and a 3.0x200 armada balloon was used without issue to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was not returned for evaluation.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 incidents and/or complaints from this lot.It should be noted that the percutaneous transluminal angioplasty (pta) catheter, armada 14, global, ce, instruction for use (ifu), states: place the prepared catheter over a pre-positioned guide wire and advance the tip to the introduction site.In this case, it is unknown if the reported ifu deviation caused or contributed to the reported difficulty.The investigation determined the reported difficulty advancing the device in the anatomy and balloon rupture appear to be related to operational context; however, a conclusive cause for the reported difficulty inserting the device over the guide wire could not be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

Subsequent to to the initial filed report, the following information was received: the guide wire was removed and then a second guide wire was attempted to be advanced through the armada port, while at the target lesion, in order to inject contrast for imaging purposes.No additional information was provided.

• Brand Name: ARMADA 14 PTA CATHETER
• Type of Device: 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: 16640080
• MDR Text Key: 312414986
• Report Number: 2024168-2023-03187
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648156106
• UDI-Public: 08717648156106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2030-120
• Device Catalogue Number: A2030-120
• Device Lot Number: 2070841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1