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

Model Number	A1020-020
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.It has reportedly been discarded.Investigation is not yet complete.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 common iliac artery.A 2.0x20mm armada 14 was attempted to to be inflated; however, it only partially inflated.A leak was noted on the joint between the hub and the shaft during the first inflation.Another non-abbott device was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.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.Based on the information provided, a conclusive cause for the reported inflation issue and leak could not be determined.It may be possible that the inflation device was not properly connected to the sidearm; however, without having the device to examine, a conclusive cause could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
Additional Manufacturer Narrative
A visual and functional analysis was performed on the returned device and noted the inflation port was cracked.The reported inflation issue and leak 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 similar incidents and/or complaints from this lot.Based on the information provided and evaluation of the returned unit, the reported inflation issue and leak were due to the cracked inflation port.Although the source of the crack could not be determined, this type of damage is consistent with over-tightening or cross threading of an inflation device or syringe causing the luer to crack from the treaded area.It may be possible that the rotator on the inflation device was over-tightened causing the sidearm to crack the threads; 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.D9 - device available for eval updated from "no" to "yes".H3- device evaluated by manufacturer updated from "no" to "yes".H6- type of investigation: code 4115 (device discarded) and investigations findings code 3221 (no findings available) were removed.Code 4582 (no clinical signs, symptoms or conditions was added.

• 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: 11629607
• Report Number: 2024168-2021-02858
• Device Sequence Number: 16868700
• Product Code: DQY
• UDI-Device Identifier: 08717648155666
• UDI-Public: 08717648155666
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2021

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: 05/31/2022
• Device Model Number: A1020-020
• Device Catalogue Number: A1020-020
• Device Lot Number: 8121341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 05/14/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/27/2021; 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1