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

Model Number	F2020-020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a 2.0x20mm armada 14 balloon dilatation catheter (bdc) was attempted to be inflated when a leak was noticed from the guide wire (gw) port.The bdc was removed, and another balloon was used to complete the procedure.There was no reported adverse patient effect or a clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the complaint information and analysis of the returned unit.The inflation problem and leak were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no indication of a lot specific issue.Based on the information provided, the investigation was unable to determine a root cause for the reported inflation / leak difficulties.In this case, it is possible, handling or environmental conditions caused a delamination leading to the reported leak, however this could not be confirmed via records review, similar incidents, or scanning electron microscopy (sem) analysis.Based on the investigation and the available information, there is no indication to suggest a product quality issue with respect to manufacture, design, or manufacture, or labeling of the device.

• 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: 15664150
• Report Number: 2024168-2022-11020
• Device Sequence Number: 17738745
• Product Code: LOX
• UDI-Device Identifier: 08717648182938
• UDI-Public: 08717648182938
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 01/31/2025
• Device Model Number: F2020-020
• Device Catalogue Number: F2020-020
• Device Lot Number: 20204G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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