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

Model Number	A2025-120
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2020
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 lesion located in the tibial artery.The armada balloon dilatation catheter was advanced to the lesion and during balloon inflation at 3 atmospheres, a leak was noted at the tip of the device.The device was removed without issue.There was no reported adverse patient effect or a clinically significant delay in the procedure.A non-abbott balloon catheter was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 other incidents.The investigation was unable to determine a conclusive cause for the leak.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Device not available for evaluation.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported leak was confirmed.The investigation was unable to determine a conclusive cause for the leak.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10, h3 - device was available for evaluation h6: method code 4114 - removed.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9655391
• Report Number: 2024168-2020-01099
• Device Sequence Number: 11321496
• Product Code: DQY
• UDI-Device Identifier: 08717648156045
• UDI-Public: 08717648156045
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2020

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: 07/31/2022
• Device Model Number: A2025-120
• Device Catalogue Number: A2025-120
• Device Lot Number: 9021941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 01/11/2020
• Supplement Date Received by Manufacturer: 04/29/2020; 07/09/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 04/30/2020; 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1