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

Model Number B1080-040

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional armada device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat an aorta bifurcation.An 8x40mm armada 35 balloon was advanced to the lesion and was inflated 1-2 times at 8 atmospheres (atms) when it ruptured and a piece (around 1 to 2mm length) of balloon released in the artery.Another 8x40mm armada 35 balloon was inflated once and burst at 8 atms.It was decided to attempt to retrieve the balloon portion that separated from the first armada 35 but it wasn't possible.Therefore, a stent was used to embed the separated balloon piece to the vessel wall.The patient was transferred to the intensive care unit afterwards.On day 4, the patients clinical condition was hemodynamically good.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

A visual analysis and a scanning electron microscopy (sem) analysis were performed on the returned unit.The balloon rupture and separation were confirmed.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 similar complaints.Based on the information provided, the balloon rupture and separation appear to be due to case circumstances.It is likely that the balloon rupture and subsequent separation occurred due to interaction with the calcified lesion causing damage to the outer surface of the balloon material leading to the rupture and separation.The additional therapy to attempt removal and embed 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.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10720627
• MDR Text Key: 212705723
• Report Number: 2024168-2020-08846
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: 08717648154867
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: B1080-040
• Device Catalogue Number: B1080-040
• Device Lot Number: 00521G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention