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

Model Number	A2025-040
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
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 the procedure was to treat the moderately calcified and moderately tortuous anterior tibial artery.The 2.5x40 mm armada 14 percutaneous transluminal angioplasty (pta) catheter was advanced on a command guide wire and positioned over the lesion; however, the balloon would not inflate at all and there was contrast leaking from the tip of the balloon.Inflation was attempted twice, once at 8 atmospheres and once at 10 atmospheres.The armada 14 pta catheter was removed and a non-abbott balloon was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned balloon catheter and the reported material rupture and inflation issues 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 incidents and/or complaints reported from this lot.Inner member damage resulting in leaks, ruptured or inflation issues can be affected by numerous factors such as damaged during processing of the device materials, handling/manipulation, damaged guide wire, inflation technique, interactions with other devices, anatomical conditions, or insufficient preparation/flushing.The investigation was unable to determine a conclusive cause for the noted inner member tear; however, the reported inflation issue and material rupture appear to be related to case circumstances of the procedure and likely due to the noted inner member tear.The noted uneven balloon marker is likely due to uneven heat travel during manufacturing; however, the marker length is with is specification.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 13005574
• Report Number: 2024168-2021-11584
• Device Sequence Number: 20065127
• Product Code: DQY
• UDI-Device Identifier: 08717648156014
• UDI-Public: 08717648156014
• 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): 03/14/2022

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: 10/31/2024
• Device Model Number: A2025-040
• Device Catalogue Number: A2025-040
• Device Lot Number: 1052541
• 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: 11/24/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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: COMMAND GUIDE WIRE; INDEFLATOR
• Patient Sex: Unknown