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

Model Number B1070-080

Device Problem Difficult to Remove (1528)

Patient Problem Aneurysm (1708)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a procedure to treat thrombosis in the left arteriovenous (av) fistula. An armada balloon catheter was inserted, and angioplasty was performed. However, after angioplasty was performed, angiogram showed residual thrombus and an aneurysm of the av fistula. A high-grade stenosis of the av fistula was also noted. During removal of the balloon catheter, the physician stated that due to patient anatomy, the device was difficult to remove. The balloon catheter was able to be removed without causing damage to the patient. To further treat the stenosed area, a non-abbott device was successfully used. There were no adverse patient effects and 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: 11308107
• MDR Text Key: 231169798
• Report Number: 2024168-2021-01061
• Device Sequence Number: 1
• Product Code: LIT
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Device Lot Number: 01016G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• 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: 02/10/2021 Patient Sequence Number: 1