MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number A2040-120

Device Problems Inflation Problem (1310); Material Rupture (1546); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the moderately calcified, 60% stenosed left popliteal and tibial arteries.The 4x120mm armada 14 percutaneous transluminal angioplasty (pta) balloon catheter was advanced without resistance, but when attempting to inflate the balloon, the pta completely failed to inflate despite holding pressure.The device was removed with no issue; however, the shaft was noted to be smashed, and a balloon rupture had occurred at an unknown pressure.A 3x120mm armada was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.Visual and functional analysis was performed on the returned device.The reported shaft damage and balloon rupture was confirmed.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 indication of a lot specific product issue.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the rupture occurred due to interaction with lesion calcification.Additionally, the damage to the shaft was also likely related to anatomical conditions.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9038923
• MDR Text Key: 169515632
• Report Number: 2024168-2019-11783
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648156168
• UDI-Public: 08717648156168
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: A2040-120
• Device Lot Number: 8060541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 39