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

Model Number A2020-120

Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

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 Description

It was reported the procedure was to treat a 90% stenosed, heavily calcified and moderately tortuosity lesion in the anterior tibial artery.A command es guide wire successfully crossed the lesion.A 2.0x120mm armada 14 balloon catheter was prepared with normal saline and was advanced to the lesion.The command es guide wire was withdrawn and then attempted to be advanced through the balloon catheter to dilate the anterior tibial artery.The guide wire met resistance when advancing through the balloon catheter and failed to pass after repeated attempts.After withdrawing the balloon catheter, it was noted that the inner member of the shaft was torn.The procedure was successfully completed with a new 2.0x120mm armada 14 balloon catheter.There were no reported adverse patient effects and no reported clinically significant delay reported.No additional information was reported.

Manufacturer Narrative

The device was returned for analysis.The reported tear was not confirmed.The reported difficult advancing the device could not be replicated in a testing environment as it was based on operational circumstances.The noted stretching and kink on the device were likely caused when advancing through the balloon catheter and failed to pass after repeated attempts and removal of the bdc.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.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10503023
• MDR Text Key: 205953564
• Report Number: 2024168-2020-07457
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648155987
• UDI-Public: 08717648155987
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• 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: 10/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: A2020-120
• Device Catalogue Number: A2020-120
• Device Lot Number: 9121641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: COMMAND ES.; GUIDE WIRE: COMMAND ES.