MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B2040-120

Device Problems Leak/Splash (1354); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) - permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.(b)(4).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 Description

It was reported that the procedure was performed to treat a moderately calcified, mildly tortuous popliteal artery that was 91% stenosed.A 4.0x120 armada 35 balloon dilatation catheter (bdc) leaked from the inflation port while inflating the balloon.Reportedly, the armada 35 was not prepped (air aspirated) prior to use.A new 4.0x80mm armada bdc 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.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The leak was not confirmed.However, a balloon rupture was 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 of the reported lot revealed no other incidents.The armada 35 instruction for use (ifu) describes preparation of the pta catheter prior to insertion into the anatomy.The investigation determined that the balloon rupture likely occurred due to case circumstances.It is likely that the rupture occurred due to interaction with lesion calcification which was described as moderately calcified, mildly tortuous popliteal artery that was 91% stenosed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Additional information: device analysis did not confirm the leak from the hub and noted leakage from the balloon.It was confirmed from the account that the rupture occurred during the procedure.The balloon ruptured at 3atms on the first inflation.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8970098
• MDR Text Key: 156764187
• Report Number: 2024168-2019-11531
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155123
• UDI-Public: 08717648155123
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: B2040-120
• Device Lot Number: 80616G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Date Manufacturer Received: 11/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1