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

Model Number	A2040-120
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing non-conformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.It should be noted that the instructions for use (ifu), for the armada 14, states: inflation in excess of the rbp may cause the balloon to rupture.Use of a pressure monitoring device is recommended.In this case, the physician was aware of the ifu violation and the balloon inflation above rated burst pressure.The device was prepped prior to use and inflated multiple times prior to the balloon rupture without any issue noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the ten (10) previous inflations likely weakened the balloon ultimately resulting in the reported balloon rupture when inflated above rated burst pressure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the left superficial femoral artery that was a chronic total occlusion.During the 11th inflation to 18 atmospheres, which was above the rated burst pressure, the armada 14 balloon ruptured.The procedure was complete at that point.There was no reported adverse patient effect and no clinically significant delay in the 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: 10535488
• Report Number: 2024168-2020-07702
• Device Sequence Number: 3934366
• Product Code: DQY
• UDI-Device Identifier: 08717648156168
• UDI-Public: 08717648156168
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 09/15/2020

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: 11/30/2022
• Device Model Number: A2040-120
• Device Catalogue Number: A2040-120
• Device Lot Number: 9061241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 73