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

Catalog Number UNK ARMADA 14 XT OTW

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

Patient Problems Aneurysm (1708); 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

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¿.

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.

Manufacturer Narrative

B3: estimated date.D4: the udi# is unknown because the part and lot numbers were not provided.D4 and h4: the device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A definitive cause of the reported thrombosis, embolism, perforation, dissection, occlusion, renal failure, hypertension, pseudoaneurysm, aneurysm, arrhythmia, hematoma, hemorrhage and the relationship to the product, if any cannot be determined.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 12740634
• MDR Text Key: 280082107
• Report Number: 2024168-2021-09887
• 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: Other
• 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: Health Professional
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention