MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

Model Number B2060-040

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2021

Event Type  Injury  

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 patient came in due to a stroke and the procedure was to treat a mildly calcified vessel in the left carotid artery. Pre-dilatation was performed with a 4. 0x40mm armada balloon without issue. Thrombectomy was performed. The 6. 0x40mm armada percutaneous transluminal angioplasty (pta) catheter was prepared (air aspiration) outside the anatomy prior to use without any issues. There was no resistance during advancement through a telescoping catheter. However, the armada was inflated once to nominal pressure and the balloon ruptured. It was noted that when removing the balloon, there was resistance noted as the balloon would not pull back into the catheter. The balloon and catheter were then proceeded to be pulled out together. The patient had prior stents in the iliacs. There was resistance felt as the balloon was being pulled out through the iliacs and the tip separated. The tip was left in the patient free floating in the aorta around the level of the renal artery. There was no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: ARMADA 35 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 COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13192123
• MDR Text Key: 283406386
• Report Number: 2024168-2022-00234
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155260
• UDI-Public: 08717648155260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: B2060-040
• Device Catalogue Number: B2060-040
• Device Lot Number: 90917G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/07/2022 Patient Sequence Number: 1

Treatment

TELESCOPING CATHETER