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

Catalog Number 1013466-100

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.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 to treat a moderately calcified proximal superficial femoral artery that was 90% stenosed.During post-dilatation, a 4x100mm armada balloon dilatation catheter was inflated 4-5 times at unspecified atmospheres when it was noted that the balloon did not inflate the entire length of the previously implanted stent as expected, but continued to use it to complete stent apposition.The balloon is reported to be miss-sized in accordance with the labeled size.There were no issues with the actual balloon inflation.Once removed out of the anatomy, it was noted that the balloon was shorter than it should be.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported undersized balloon was not 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 device met specification.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: 9304558
• MDR Text Key: 177213288
• Report Number: 2024168-2019-13410
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648207983
• UDI-Public: 08717648207983
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 1013466-100
• Device Lot Number: 9060541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/25/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1