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

Model Number 1013468-200

Device Problems Failure to Fold (1255); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

The other command 18 guide wire referenced being filed under a separate medwatch report number.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 a procedure was performed to treat a lesion in the left superficial femoral artery.A command 18 guide wire was advanced with a 5x200 armada 18 percutaneous transluminal angioplasty (pta) catheter without resistance.The armada was inflated, and the balloon folds were bunched after deflation.The guide wire and pta faced resistance with each other during removal, so the devices were removed together.The polymer of the command guide wire was peeled.It was confirmed that no portion of the devices remain in the anatomy.An unspecified command guide wire and unspecified armada pta were 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, dimensional and functional inspections were performed on the returned balloon catheter.The reported balloon bunching was not confirmed.The reported difficulty to remove was unable to be confirmed and a proxy ht command wire was able to advance and retracted without any resistance noted.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 reported from this lot.The investigation determined the reported balloon folding issues appear to be related to operational circumstances of the procedure.It is likely that the balloon was not fully deflated during retraction causing the balloon to deflate flat and to become twisted against the anatomy and or other devices used, also causing the appearance of a bunched balloon.However, the reported difficulty to remove the guide wire appears to be related to the noted polymer damages.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: 9720202
• MDR Text Key: 180133501
• Report Number: 2024168-2020-01561
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648208249
• UDI-Public: 08717648208249
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1013468-200
• Device Catalogue Number: 1013468-200
• Device Lot Number: 9102441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMMAND 18 GUIDE WIRE
• Patient Age: 83 YR
• Patient Weight: 78