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

Model Number B1080-040

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis. The balloon rupture and separation were confirmed via photos provided by the account. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other complaints. Based on the information provided, the balloon rupture, separation and difficult to remove appear to be due to case circumstances. It is likely that the balloon rupture, difficult to remove, and subsequent separation occurred due to interaction with anatomical structures or other devices within the anatomy or as a result of the use of a non pressure monitored inflation device. The additional therapy to remove the separated portion was due to the case circumstances. 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 procedure was performed to treat an atrioventricular fistula with mild tortuosity and 80% stenosis. An 8 x 40mm armada 35 balloon dilation catheter (bdc) was prepped without any issues and advanced to the target lesion without any resistance; however, while attempting to inflate the balloon of the bdc, the balloon ruptured after two inflations at an unknown pressure. It was noted that the physician inflated the balloon by hand; therefore, it is unknown if the balloon was inflated beyond nominal pressure. While attempting to remove the balloon, resistance was noted with the anatomy and a portion of the balloon detached and remained in the anatomy. A snare device was then inserted, and the detached pieces were successfully retrieved from the anatomy. There was no reported 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: 10857252
• MDR Text Key: 216836577
• Report Number: 2024168-2020-09651
• 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
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: B1080-040
• Device Catalogue Number: B1080-040
• Device Lot Number: 00527G1
• 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: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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: 11/17/2020 Patient Sequence Number: 1