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

Model Number 1013470-200

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The command guide wire referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a lesion with heavy calcification in the right superficial femoral artery (sfa).The armada 18 balloon catheter was advanced over the command guide wire; however, resistance was noted between the distal end of the balloon catheter and the guide wire.The balloon catheter reached the target lesion and the balloon was inflated.During removal of the balloon catheter, there was resistance with the wire and sheath.It was noted that the balloon had separated and was stuck on the guide wire.The separated balloon remained on the guide wire; therefore, all devices were simply removed as one unit from the patient anatomy without consequences.It was confirmed that there was nothing left behind in the patient.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Additional information reported that it was the distal shaft with the balloon that separated and not just the balloon.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported resistance with the guide wire and separation of the shaft 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 incidents.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the kinks noted in the guide wire contributed to the reported resistance with the balloon catheter and as a result, caused the devices to become frozen together.Further manipulation of the devices likely caused the separations of the armada 18.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: 9758322
• MDR Text Key: 181160432
• Report Number: 2024168-2020-01799
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648208461
• UDI-Public: 08717648208461
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1013470-200
• Device Catalogue Number: 1013470-200
• Device Lot Number: 9091741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7 FR COOK GUIDING CATHETER; COMMAND GUIDE WIRE; 7 FR COOK GUIDING CATHETER; COMMAND GUIDE WIRE
• Patient Age: 73 YR
• Patient Weight: 115