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

Model Number A2020-120

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported inflation issue and balloon rupture were 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 other incidents.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the balloon rupture occurred due to interaction with calcification or associated devices during use.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

Event Description

It was reported that the procedure was performed to treat a lesion in the anterior tibial artery.A 2x120mm armada 14 percutaneous transluminal angioplasty (pta) was advanced without resistance.The balloon completely failed to inflate while losing pressure as a balloon rupture was noted.A 2.5x60mm armada 14 pta was advanced, and the balloon partially inflated only up to 4 atmospheres but was also losing pressure as a pinhole balloon rupture was noted.A 2x60mm armada balloon 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.

• Brand Name: ARMADA 14 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11388439
• MDR Text Key: 238603863
• Report Number: 2024168-2021-01524
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648155987
• UDI-Public: 08717648155987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: A2020-120
• Device Catalogue Number: A2020-120
• Device Lot Number: 0013141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1