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

Model Number B2060-040

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. Based on the information provided, a conclusive cause for the reported leak could not be determined. It may be possible that the inflation device was not properly connected to the sidearm; however, without having the device to examine, a conclusive cause could not be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the during device preparation of the armada 35 dilatation catheter, the device was noted to pull air and was not used. There was no patient involvement and no clinically significant delay in the procedure. A second same device was used without issue. 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: 10814383
• MDR Text Key: 215528258
• Report Number: 2024168-2020-09360
• 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
• Report Date: 11/09/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: B2060-040
• Device Catalogue Number: B2060-040
• Device Lot Number: 00529G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial