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

Catalog Number 1013466-100

Device Problem Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.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.The distance between the markers on the returned product was within specification and there is no indication of a product quality issue with respect to manufacture, design, or labeling.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number e2019001.

Event Description

It was reported that the 4.0x100 armada 18 balloon dilatation catheter was inserted to post dilate the 6.0x100 absolute pro vascular stent in the superficial femoral artery.When the armada was inflated to nominal pressure, it appeared to be the correct 100 mm length; however, the balloon markers did not line up with the shoulders of the balloon.The markers appeared shorter than the 100 mm length.The stent was successfully postdilated and there were no adverse patient effects.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 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: 9305536
• MDR Text Key: 170358907
• Report Number: 2024168-2019-13428
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648207983
• UDI-Public: 08717648207983
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• 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,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2019
• 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