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

Model Number	A1030-080
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device will not be returned for evaluation, the device was reportedly discarded.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 number.
Event or Problem Description
It was reported that the procedure was to treat the moderately calcified tibial artery.The command guide wire was inside of an armada percutaneuous transluminal angioplasty (pta) catheter and tip of the guide wire broke off in the distal tibial vessel.The tip was retrieved via snare.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.Additional information received 12/08/2019 indicates that the command guide wire was advanced without resistance.There was difficulty during withdraw of the armada balloon and the guide wire.Some force was required and both the guide wire and the armada balloon were removed together.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.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 revealed no other similar incidents reported for this lot.The investigation determined the reported difficulty to remove appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement through the moderately calcified anatomy, the 014 ht command guide wire became kinked.Manipulation and/or inadvertent mishandling of the guide wire during the procedure, likely resulted in the core and polymer separation.The difficulty to remove was likely caused by the kinks noted on the guide wire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9521887
• Report Number: 2024168-2019-15014
• Device Sequence Number: 16258034
• Product Code: DQY
• UDI-Device Identifier: 08717648155819
• UDI-Public: 08717648155819
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: A1030-080
• Device Catalogue Number: A1030-080
• Device Lot Number: 9052741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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 GUIDE WIRE
• Patient Age: 70 YR