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

Model Number B2070-200

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The other armada 35 device referenced is in the filed under a separate medwatch report number.

Event Description

It was reported that during a severely stenotic left superficial femoral artery (sfa) intervention, two armada balloon catheters were used and ruptured.The first armada balloon ruptured during the 1st inflation at 6 atmospheres (atm).The second armada ruptured during the 1st inflation, at 7 atm.The devices were removed without issue.There was no adverse patient effect and no clinically significant delay in the procedure.The procedure was successfully completed with an unspecified device.No additional information was provided.

Manufacturer Narrative

Visual and functional inspections were performed on the returned balloon catheter, and the reported balloon rupture was confirmed.Additionally, it was noted that there were multiple scratches on the balloon distal to the rupture.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 incidents and/or complaints reported from this lot.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement through the severely stenosed anatomy, the outer surface of the balloon became compromised and/or damaged resulting in the reported balloon rupture during the first inflation to 7 atmospheres.The noted scratches at the rupture site also suggests interaction causing damage to the outer surface of the balloon material.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 11369816
• MDR Text Key: 234619919
• Report Number: 2024168-2021-01414
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155413
• UDI-Public: 08717648155413
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: B2070-200
• Device Catalogue Number: B2070-200
• Device Lot Number: 00418G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 93