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

Model Number	A2020-200
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the left peroneal artery with right groin access.A spartacore guide wire was advanced and the 2.0x200mm armada 14 balloon catheter was advanced.There was no difficulty removing the stylet or protective sheath and the balloon was prepared/flushed prior to use.The balloon was attempted to be inflated but there was a lot of resistance.It took a lot of pressure to inflate the balloon and it was only partially inflated and not uniformly shaped.The device was losing pressure but there was no leak of contrast noted in the vessel as the balloon was inflating, nor was there any blood backfilling the inflation device so it was difficult to tell if there was a rupture.When attempting to remove the armada balloon, it became stuck with the spartacore guide wire in the superficial femoral artery and they were pulled out together, causing wire access to be lost.There was no attempt made to move the guide wire while the balloon was pressurized/inflated.The physician noted a thread of what seemed to be plastic material at the hub of the armada sheath and pulled it out without intervention.It was a long plastic material but angiography post procedure confirmed nothing remained in the patient.A command18 guide wire was advanced and a 1.5x40mm armada 14 and 2.5x200mm armada balloon catheters were used to complete the procedure.Angiogram followed revealing in line flow down to foot.There was no adverse patient effect, however, there was a delay in the procedure but no harm to the patient.No additional information was provided.
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 spartacore guidewire is being filed under a separate medwatch report number.
Additional Manufacturer Narrative
A visual inspection and fourier transform infrared spectrometer (ftir) testing was performed on the returned device.The reported difficulty removing the device from the guide wire and the contamination / decontamination problem (long plastic material) were confirmed.The reported leak, inflation issue and the balloon not being uniformly shaped could not be replicated in a testing environment due to the condition of the returned 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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Returned device analysis noted that the guide wire poked through a noted tear on the inner member, distal to the proximal seal.In this case, it is likely that the proximal end of the guide wire inadvertently punctured through the inner member during backloading resulting in the reported leak, inflation issue and subsequently gave the perception of the balloon not being uniformly shaped since the device was not holding pressure.The reported difficulty removing the device from the guide wire likely resulted from the same noted tear in the inner member on the returned device.Additionally, the reported unknown clear material was sent for ftir testing to the chem lab.The ftir report determined that the unknown material was identified as ptfe or teflon strip with blood.Further evaluation was performed, and it was determined that the unknown material was possibly from the guiding catheter used during the procedure and not an abbott component; however, a conclusive cause could not be determined since the guiding catheter used in the procedure was not returned for analysis.There is no indication of a product quality issue with respects 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14734853
• Report Number: 2024168-2022-06558
• Device Sequence Number: 5583022
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: 08717648155994
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 04/30/2025
• Device Model Number: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 1110841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPARTACORE GUIDEWIRE
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 67 KG