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

Model Number	F2015-020
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the anterior tibial artery with moderate calcification and mild tortuosity.The 1.50x20mm armada balloon dilatation catheter (bdc) was attempted to advanced to the target lesion; however, failed to cross due to the anatomy.During, removal the the bdc a guidewire (gw) became stuck with the bdc and difficulty was also noted due to the patient's anatomy.The catheter of the bdc broke while forcing the gw out of the bdc.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported break was confirmed.The reported difficulty advancing and removing the device could not be replicated in a testing environment as it was based on operational circumstances.The reported difficulty removing the device from the guide wire 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 difficulty advancing the device and removing the device from the anatomy and brake appear to be related to operational context; however, a conclusive cause for the reported difficulty removing the device from the guide wire could not be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to initial report being filed the return device analysis found the inner member and outer member were separated in multiple locations throughout the bdc.The bdc was returned in five separate pieces.The balloon had been inflated the account confirmed the correct device was returned and the separation and balloon inflation occurred of post-procedure manipulation and not in the patient.No additional information was provided.

• Brand Name: ARMADA 14 XT 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 COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16818845
• Report Number: 2024168-2023-04353
• Device Sequence Number: 7125047
• Product Code: LOX
• UDI-Device Identifier: 08717648182884
• UDI-Public: 08717648182884
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K121352
• 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): 06/20/2023

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: 09/30/2025
• Device Model Number: F2015-020
• Device Catalogue Number: F2015-020
• Device Lot Number: 21020G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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