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

Catalog Number UNK ARMADA 35 OTW LL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Hematoma (1884); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Renal Failure (2041); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated date. The udi number is "ni" as the part number was not provided. The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional patient effects, malfunctions, and devices referenced in the report are captured under separate medwatch report numbers. Literature titled ¿post market clinical follow-up evaluation report peripheral dilatation catheter family¿.

Event Description

The post-market clinical follow-up (pmcf) report, titled ¿post market clinical follow-up evaluation report peripheral dilatation catheter family¿ evaluated the safety and performance of the viatrac 14 plus, armada 14, armada 14xt, armada 18, armada 35, and the armada 35 ll. It was reported through a pmcf report that the armada 35 ll may be related to unsuccessful dilatation of a vessel, stent, and/or chronic total occlusion, unsuccessful delivery, inflation, and/or deflation, embolism, dissection, perforation, total occlusion, abrupt closure, arrhythmia, renal failure, thrombosis, occlusion, venous hypertension, pseudoaneurysm, hematoma, and hemorrhagic events. Although the above events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the abbott dilatation catheters met the safety and performance criteria and perform similarly to competitive state of the art devices.

• 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: 12741135
• MDR Text Key: 279827105
• Report Number: 2024168-2021-09897
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK ARMADA 35 OTW LL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 11/02/2021 Patient Sequence Number: 1