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

Model Number	A2020-120
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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armada 14 balloon catheter was prepared with normal saline and was advanced to the lesion.The command es guide wire was withdrawn and then attempted to be advanced through the balloon catheter to dilate the anterior tibial artery.The guide wire met resistance when advancing through the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.
Additional 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
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10503023
• Report Number: 2024168-2020-07457
• Device Sequence Number: 16978367
• Product Code: DQY
• UDI-Device Identifier: 08717648155987
• UDI-Public: 08717648155987
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: COMMAND ES.; GUIDE WIRE: COMMAND ES.