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

Model Number	A2025-200
Medical Device Problem Codes	Deflation Problem (1149); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
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 an anterior tibial artery.A 2.5x200mm armada 14 was advanced to the lesion and inflated once at 12 atmospheres without issue.However, when attempting to deflate, the device was held negative for over 5 seconds but the balloon took a prolonged time to eventually deflate completely so that it can be used for another lesion.When attempted to advance to another lesion, it failed to cross.It was decided then to simply remove the device.A 2.5mm balloon was used to successfully complete the procedure.There were 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 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 similar incidents reported from this lot.Without having the device to examine, the investigation was unable to determine a conclusive cause for the reported deflation and failure to advance difficulties.It may be possible that the distal shaft was kinked or entrapped within the vessel causing the inflation/deflation lumen to become blocked off; therefore, after an attempt to insert in the other lesion it was unable to advance; 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.

• Brand Name: ARMADA 14 OTW
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10853028
• Report Number: 2024168-2020-09605
• Device Sequence Number: 3489381
• Product Code: DQY
• UDI-Device Identifier: 08717648156052
• UDI-Public: 08717648156052
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 11/30/2023
• Device Model Number: A2025-200
• Device Catalogue Number: A2025-200
• Device Lot Number: 0061641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR