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

Catalog Number 1014254-040

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the chipboard box was labeled as a 3.0x80mm armada 18 but the inner pouch was labeled as 3.0x80mm armada 14.The nurse didnt notice that it was the wrong size and attempted to load the catheter on a command 18 st 300 wire but was unsuccessful.A new 3.0x80mm armada 18 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

Visual analysis was performed on the returned device.In addition, shipment history records to this account were reviewed.The reported information of the armada 14 device in the armada 18 box 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 other complaints reported from this lot.It should be noted that the armada 18 instruction for use states: ¿carefully inspect the catheter prior to use to verify that it 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.¿ the investigation was unable to determine a definitive cause for the reported difficulty.However, based on the reported information, evaluation of the returned product, and reviewed shipment records for this account, it may be possible that during a different procedure, the armada 18 and armada 14 products were opened together, and it was decided not to use the armada 14 device.It may then be possible that the unopened armada 14 pouch was inadvertently placed back into the empty armada 18 box instead of the armada 14 box and placed back on the shelf.However, this could not be confirmed.The reported difficulty attempting to load the armada14 catheter on a command 18 guide wire was due to the armada 14 requiring an 0.014¿¿ guide wire and it was not notice that it was the wrong catheter in the chipboard box.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 11354918
• MDR Text Key: 234206816
• Report Number: 2024168-2021-01339
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 1014254-040
• Device Lot Number: 0082041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMMAND 18 ST 300