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

Model Number	A2030-080
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the anterior tibial artery with 75% stenosis, moderate calcification and mild tortuosity.A command es guide wire was inserted.There was no difficulty removing the protective sheath and the 3.0x80mm armada 14 balloon dilatation catheter (bdc) was advanced but when attempting to inflate the balloon at nominal pressure, the balloon did not open to its full profile as there was leakage in the hub.The bdc was removed.Another 3.0x120mm armada balloon 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.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Additional Manufacturer Narrative
The device was not returned for analysis.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 incidents from this lot.Based on the information provided, the reported inflation and leak were due to the cracked inflation port.Although the source of the crack could not be determined, this type of damage is consistent with over-tightening or cross threading of an inflation device or syringe causing the luer to crack from the threaded area.It may be possible that the rotator on the inflation device was over-tightened causing the sidearm to crack the threads; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3 - device returning update from yes to no.
Additional Manufacturer Narrative
Visual, functional and sem analysis were performed on the returned device.The reported inflation issue and leak were 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 balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the inner member leak may be attributed to mechanical damage to the outer surface.The diagonal leak was located at the proximal end of the inflation port.The damage extended to the adhesive at the proximal end of the port.Additional mechanical damage was documented adjacent to and distal to the leak area.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.D9, h3 device return status changed from no to yes.H6: component code: 4755 removed; 4729, 419, 829 added.H6: type of investigation code: 4114 removed; 10 added.H6: investigation findings code: 3221 removed; 114 added.H6: investigation conclusions code: 4315 removed; 4307 added.

• 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: 17302137
• Report Number: 2024168-2023-07376
• Device Sequence Number: 7064098
• Product Code: DQY
• UDI-Device Identifier: 08717648156090
• UDI-Public: 08717648156090
• 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,Followup
• Report Date (Section B): 03/05/2024

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: 04/30/2026
• Device Model Number: A2030-080
• Device Catalogue Number: A2030-080
• Device Lot Number: 2110741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 02/20/2024
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 11/30/2023; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND ES GUIDE WIRE.
• Patient Sex: Unknown