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

Model Number A2030-200

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a superficial femoral artery.A 3x200mm armada balloon was prepped per the instructions for use.It was then advanced to the lesion without resistance noted.The balloon was inflated once for 2 minutes at 8 atmospheres when it was noted that the shaft (guide wire exit notch area) was leaking.The balloon was only able to partially inflate.The device was simply removed and another armada was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual, functional and scanning electron microscopy (sem) analysis was performed on the returned device.The reported inflation issue and leak were confirmed.Sem was performed to attempt to identify the source of the leak.Results of the sem analysis concluded that the balloon failure may be attributed to mechanical damage to the outer surface.Additional leak origin areas in the inner member or bonded regions of the luer could not be identified.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.The investigation was unable to determine a cause for the reported difficulties.Based on the evaluation of the returned unit and sem analysis results, the balloon failure may be attributed to mechanical damage to the outer surface which may have occurred due to interaction with calcification or associated devices.Additional leak origin in the inner member or bonded regions of the luer could not be identified.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: ARMADA 14 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11332621
• MDR Text Key: 233457550
• Report Number: 2024168-2021-01210
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648156113
• UDI-Public: 08717648156113
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: A2030-200
• Device Catalogue Number: A2030-200
• Device Lot Number: 9012341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 46