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

Model Number	A2015-120
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned balloon catheter.The reported difficulty to advance and difficulty to remove were unable to be confirmed and a proxy guide wire was able to advance and retract without any resistance noted.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 advance/position and difficulty to remove the guide wire through the balloon catheter appear to be related to operational circumstances of the procedure.In this case, it is likely that the calcified anatomical conditions were the cause if the reported failure to advance the guide wire which resulted in the reported difficulty to advance and retract the guide wire through the distal end of the balloon catheter.The noted balloon damages and placement of the proximal balloon marker were likely due to manipulation during retraction against resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional unk ht command 14 device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was treat an anterior tibial artery (ata).A 1.5x120mm armada percutaneous transluminal angioplasty catheter was advanced over the 14 command guide wire to cross a lesion; however, the guide wire retracted due to the calcification and back into the balloon catheter.The guide wire would not advance through the distal portion of the balloon catheter and became stuck with the balloon catheter.The guide wire and catheter were removed together.Another unspecified balloon and command guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay reported.No additional information was provided.

• 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: 11379139
• Report Number: 2024168-2021-01471
• Device Sequence Number: 14447159
• Product Code: DQY
• UDI-Device Identifier: 08717648155932
• UDI-Public: 08717648155932
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: A2015-120
• Device Catalogue Number: A2015-120
• Device Lot Number: 0052142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR