MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2025-200
Medical Device Problem Codes	Difficult to Insert (1316); Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional ht command es device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified left fibular artery.A 2.5x200mm armada 14 percutaneous transluminal angioplasty (pta) catheter had difficulty being inserted onto a command 14 guide wire, and the devices faced resistance with each other during positioning.The pta balloon would not maintain inflation.A 2.5x120mm armada 14 pta was used with the same command guide wire to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional testing was performed on the returned balloon dilatation catheter (bdc) which identified a balloon puncture and a dislodged balloon marker.Follow-up with the site confirmed the correct device was returned; however, the site was unaware of the balloon puncture and dislodged balloon marker.The reported difficulty to insert, difficult to advance the guide wire and leak were 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 and/or complaints reported from this lot.The device was prepped prior to use without any leaks or issues noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported difficulty to advance, difficulty to insert, and leak appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement the bdc encountered resistance with the heavily calcified anatomy reducing the clearance between the devices causing resistance.Manipulation against resistance likely caused the balloon and inner member to bunch resulting in the difficult to insert and advance the guide wire through the lumen and the noted kink on the outer member.The noted bunching on the balloon likely led to the reported leak/balloon rupture during inflation attempts.The inner member likely stretched during retraction causing the balloon marker to shift from the intended location.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no corrective action is required.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11738351
• Report Number: 2024168-2021-03598
• Device Sequence Number: 3192287
• Product Code: DQY
• UDI-Device Identifier: 08717648156052
• UDI-Public: 08717648156052
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: A2025-200
• Device Catalogue Number: A2025-200
• Device Lot Number: 0052041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 07/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1