MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1014254-100

Device Problems Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

It was reported that the procedure was performed to treat a tibial trunk.During preparation of the 3.0x100mm armada 18 balloon dilatation catheter, negative pressure was applied, and it was noticed that there was continuous air coming into the balloon.The device was used and during inflation, the balloon failed to inflate as contrast leaked from the balloon.The device was replaced with a new unspecified balloon 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

The device was not returned for analysis.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 from this lot.It should be noted that armada 18 percutaneous transluminal angioplasty (pta) catheter instruction for use, states: carefully inspect the catheter prior to use to verify that is has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.In this case, it does not appear that the instruction for use (ifu) deviation related to use after damage caused or contributed to the reported difficulties.The investigation was unable to determine a conclusive cause for the reported balloon leak.After the leak was identified during device preparation the device was used to perform the procedure and was unable to hold pressure and did not successfully inflate the device.The investigation determined the reported inflation issues appear to be related to circumstances of the procedure as it is likely the balloon leak caused the reported inflation issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9581228
• MDR Text Key: 177804227
• Report Number: 2024168-2020-00595
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K151317
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 1014254-100
• Device Lot Number: 9051341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1