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

Model Number	A2020-060
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
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 the procedure was to treat a moderately calcified, mildly tortuous tibial artery.After crossing the lesion with a command es guide wire the 2.0x60mm armada 14 dilatation catheter was noted to not fully inflate when inflated to nominal pressure as the hub was noted to be leaking.Another 2.0x40mm armada 14 was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 investigation was unable to determine a conclusive cause for the reported leak at the hub.Although a conclusive cause for the reported leak was not identified, the reported inflation issue appears to be related to operational circumstances of the procedure as it is likely due to the reported leak.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9/h3 - device available for eval updated from 'yes' to 'no'.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy inspections/analysis were performed on the returned device.The reported leak and inflation issue 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/complaints from this lot.The investigation determined a potential product quality issue based on the reported leak, inflation issue and noted inner member tears.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.D9 - device available for evaluation updated from 'no' to 'yes' h6 - component code 4755, type of investigation code 4115, investigation findings code 114 and investigation conclusions code 67 were removed h10 - additional mfg narrative: revised.

• 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: 14824251
• Report Number: 2024168-2022-06861
• Device Sequence Number: 4844273
• Product Code: DQY
• UDI-Device Identifier: 08717648155963
• UDI-Public: 08717648155963
• 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): 01/04/2023

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: 03/31/2024
• Device Model Number: A2020-060
• Device Catalogue Number: A2020-060
• Device Lot Number: 0102241
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 01/03/2023
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 09/09/2022; 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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