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

Catalog Number	A2025-060
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 clarifier- incorrect prep.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, mildly tortuous peroneal artery that is 80% stenosed.The 2.5x60mm armada 14 balloon catheter was not air aspirated outside the anatomy prior to use.Once at the lesion, the balloon would not hold pressure after inflation to nominal pressure and was noted to be deflating.However, balloon angioplasty was completed with the same armada and then the device was removed.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It was reported that the device was prepped inside the anatomy.It should be noted that the percutaneous transluminal angioplasty (pta), armada 14, global instructions for use (ifu) specifies: to perform the steps outlined 1 through 7 to remove all air and verify the integrity of the pta catheter.The instructions indicate to perform the steps outside of the patient¿s anatomy.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation determined that the reported balloon rupture appears to be related to operational context.In this case, it is likely that the balloon interacted with the moderately calcified and mildly tortuous anatomy such that the balloon became damaged and subsequently ruptured during inflation.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9: device available for evaluation updated from ¿yes¿ to ¿no¿ h3: device evaluated by mfg? updated from ¿yes¿ to ¿no¿.

• 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: 19033495
• Report Number: 2024168-2024-04164
• Device Sequence Number: 15208684
• Product Code: DQY
• UDI-Device Identifier: 08717648156021
• UDI-Public: (01)08717648156021(17)260630(10)3012341
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 06/30/2026
• Device Catalogue Number: A2025-060
• Device Lot Number: 3012341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2023
• 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 Sex: Unknown