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

Model Number	A2020-080
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the anterior tibial artery (ata) with strong calcification and a non-treatable kink in the artery due to fracture of the tibia and fibula.The 2.0x80 mm armada 14 percutaneous transluminal angioplasty (pta) catheter worked properly when it was first advanced onto a guide wire.However, when the armada 14 pta catheter was removed from the wire, rinsed and threaded onto a non-abbott guide wire, it was no longer able to advance.A new catheter was used without issue.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a stretched proximal shaft.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device and stretching was noted on the shaft proximal to the proximal seal.The reported difficulty advancing the device over the guide wire was 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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported difficulty advancing the device over the guide wire appears to be related to operational context.It was reported by the account that the 2.0x80 mm armada 14 percutaneous transluminal angioplasty (pta) catheter worked properly when it was first advanced onto a guide wire.Return analysis noted the shaft proximal to the proximal seal was stretched.In this case, it is likely that the device being previously used likely compromised the condition of the device which contributed to the resistance met when attempting to reinsert the balloon catheter over the guide wire.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 13581245
• Report Number: 2024168-2022-01873
• Device Sequence Number: 4410413
• Product Code: DQY
• UDI-Device Identifier: 08717648155970
• UDI-Public: 08717648155970
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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 Expiration Date: 01/31/2025
• Device Model Number: A2020-080
• Device Catalogue Number: A2020-080
• Device Lot Number: 1080341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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: 14 GILDEWIRE ADVANTAGE.
• Patient Sex: Unknown