MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number B1050-040

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

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 procedure was to treat a 90% stenosed lesion with no significant calcification or tortuosity in the distal superficial femoral artery.A 5x40x80 armada catheter was inserted; however, the guide wire jammed in the catheter shaft during advancement.The device was removed as a single unit.The procedure was successfully completed with a new guide wire and a new balloon catheter.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned balloon catheter; however, the reported difficulty to advance/position and difficulty to removed unable to be confirmed due to the returned condition of the device.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 similar incidents and/or complaints reported from this lot.Factors that may contribute to the difficulty to advance/position and remove the guide wire and cause resistance between the devices may include, but not limited to, device placement technique, guiding catheter support, anatomical conditions, inner diameter of guide wire lumen or delivery device, outer diameter of the guide wire, condition of the guide wire, condition of the balloon catheter, coagulation of blood or procedural contaminates.The investigation was unable to determine a conclusive cause for the reported difficulty to advance/position and difficulty to remove the guide wire.In this case, it may be possible that the guide wire was damaged during advancement through the anatomy causing damage to the inner layers of the inner member resulting in the difficulty to advance/position the wire and ultimately causing the wire to become frozen in the guide wire lumen; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9962422
• MDR Text Key: 187729760
• Report Number: 2024168-2020-03667
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154607
• UDI-Public: 08717648154607
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• 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: B1050-040
• Device Catalogue Number: B1050-040
• Device Lot Number: 90913G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: .035 GUIDE WIRE; .035 GUIDE WIRE