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

Model Number	A2020-200
Medical Device Problem Codes	Product Quality Problem (1506); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
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 complaints reported from this lot.Based on the information provided, a definitive cause for the reported damage to the proximal marker band could not be determined.It may be possible that the marker band became damaged during removal of the protective sheath; however, this could not be confirmed, and the device was not returned for evaluation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that during device preparation, it was noticed that the proximal marker band on the catheter seemed separated and had a raised bubble.A gap was felt between the marker band as if it were not a solid piece.The device was not used, there was no patient involvement and no clinical significant delay in procedure.No additional information was provided.

• 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: 12677915
• Report Number: 2024168-2021-09507
• Device Sequence Number: 4211913
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: 08717648155994
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 09/30/2024
• Device Model Number: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 1041941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1