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

Model Number	1013468-080
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.In this case, it was reported that the balloon was inflated to 16 atmospheres.It should be noted that the armada 18 instruction for use (ifu) states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 14 atmospheres as indicated on the product label.The investigation determined the reported balloon rupture and difficulty advancing the device appears to be related to operational contest.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The udi is unknown because the part/lot number were not provided.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified vessel without tortuosity in the superficial femoral artery (sfa).The armada 18 balloon catheter was soaked prior to use and was prepared (air aspiration) outside the anatomy.There was mild resistance during advancement due to the anatomy.The balloon was inflated at 14 atmospheres (atms) for the first inflation.However, the balloon ruptured during the second inflation at 16 atms.A 5.5x100mm armada was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 14621560
• Report Number: 2024168-2022-06041
• Device Sequence Number: 5367467
• Product Code: LIT
• UDI-Device Identifier: 08717648208195
• UDI-Public: 08717648208195
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/07/2022

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 Model Number: 1013468-080
• Device Catalogue Number: 1013468-080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 113 KG