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

Model Number 1013468-200

Device Problems Failure to Fold (1255); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

The other command 18 guide wire referenced being filed under a separate medwatch report number. 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 a procedure was performed to treat a lesion in the left superficial femoral artery. A command 18 guide wire was advanced with a 5x200 armada 18 percutaneous transluminal angioplasty (pta) catheter without resistance. The armada was inflated, and the balloon folds were bunched after deflation. The guide wire and pta faced resistance with each other during removal, so the devices were removed together. The polymer of the command guide wire was peeled. It was confirmed that no portion of the devices remain in the anatomy. An unspecified command guide wire and unspecified armada pta were 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.

• Brand Name: ARMADA 18 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: 9720202
• MDR Text Key: 180133501
• Report Number: 2024168-2020-01561
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1013468-200
• Device Catalogue Number: 1013468-200
• Device Lot Number: 9102441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial