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

Catalog Number UNK ARMADA 14 XT OTW

Device Problems Deflation Problem (1149); Failure to Fold (1255); Inflation Problem (1310); Failure to Advance (2524)

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

Event Date 04/09/2021

Event Type  malfunction  

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 attachment titled ¿post market clinical follow-up evaluation report peripheral dilatation catheter family¿na.

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 14 xt may be related to unsuccessful dilatation of a vessel, stent, and/or chronic total occlusion, unsuccessful delivery, inflation, and/or deflation, twisting of the balloon when used twice, embolism, dissection, perforation, limb amputation, total occlusion, abrupt closure, arrhythmia, renal failure, and thrombosis, occlusion, venous hypertension, aneurysm, 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 14 XT 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: 12740845
• MDR Text Key: 279827240
• Report Number: 2024168-2021-09890
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K121352
• 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

0 Patients were Involved in the Event:

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

Device Operator

• Device Catalogue Number: UNK ARMADA 14 XT OTW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2021
• 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