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

Model Number 1013470-150

Device Problems Failure to Fold (1255); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001. 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 performed to treat a lesion in the mildly calcified superficial femoral artery with a flux occlusion. A 5. 5x150mm and two 5. 5x100mm supera self-expanding stents were implanted without any issues. A 6x150mm armada 18 percutaneous transluminal angioplasty (pta) balloon was advanced without resistance, but during the first inflation at 6 atmospheres (atms), the middle portion of the balloon did not fully inflate until the third inflation at the same pressure. The pta balloon was now fully inflated, and post-dilatation was complete. The balloon deflated, but the balloon did not refold tightly. During removal, the balloon felt resistance with the introducer sheath, and the pta catheter was removed with the non-abbott sheath as a single unit. A new sheath was advanced for confirmation imaging. 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: 9305061
• MDR Text Key: 177209933
• Report Number: 2024168-2019-13419
• 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: 02/10/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1013470-150
• Device Catalogue Number: 1013470-150
• Device Lot Number: 9060741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial