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

Model Number	F2015-020
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional 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 lesion in the lower extremities.A 1.5x20mm armada 14 percutaneous transluminal angioplasty (pta) catheter was used with a command 14 guide wire.The devices crossed successfully, and the pta balloon was used.However, the guide wire was stuck with the pta catheter, so the devices were removed together.An unspecified guide wire and balloon 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.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device and the reported difficulty to remove 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 and/or complaints reported from this lot.The investigation determined the reported difficulty to remove appears to be related to circumstances of the procedure.It was reported both devices crossed successfully, and the pta balloon was used.In this case, it is likely manipulation of the devices during the procedure likely caused damage to the guide wire lumen or guide wire resulting in the difficulty to remove.Further manipulation against resistance, likely caused the subsequent noted damages to the balloon, inner/outer member, and tip locking the guide wire in place or to become frozen in the guide wire lumen.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: the procedure was performed to treat a lesion in the heavily calcified tibial artery.No additional information was provided.

• Brand Name: ARMADA 14 XT PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12221343
• Report Number: 2024168-2021-06424
• Device Sequence Number: 3509223
• Product Code: LOX
• UDI-Device Identifier: 08717648182884
• UDI-Public: 08717648182884
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 01/31/2024
• Device Model Number: F2015-020
• Device Catalogue Number: F2015-020
• Device Lot Number: 10204G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND 14 GUIDE WIRE
• Patient Age: 73 YR