MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013470-080
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a highly calcified superficial femoral artery and popliteal artery.A command guide wire (gw) went down, early in the case but there was noted resistance with anatomy while advancing it to the lesion, although it was able to reach the lesion.It was noticed that the tip of the wire was mangled/frayed once the gw was removed after the completion of the case.The gw became damaged from the calcium.The armada 18 balloon was taken in and out numerous times during the procedure as it was inflated to nominal pressure six times; however, on the 7th time, but the command gw would not advance through the armada balloon.There were no damages noted to the armada balloon a new armada was successfully used for the 7th inflation to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Device analysis noted that the armada 18 balloon [the material on the proximal balloon markers was torn for a length of 2.5mm].No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned device.The reported complaint 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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The command guide wire referenced is filed under a separate medwatch report number.

• Brand Name: ARMADA 18 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: 14610756
• Report Number: 2024168-2022-06031
• Device Sequence Number: 4509071
• Product Code: LIT
• UDI-Device Identifier: 08717648208416
• UDI-Public: 08717648208416
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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
• Report Date (Section B): 06/06/2022

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: 06/30/2023
• Device Model Number: 1013470-080
• Device Catalogue Number: 1013470-080
• Device Lot Number: 0010341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• 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: COMMAND GUIDE WIRE
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 102 KG