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

Model Number	A2020-060
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat an anterior tibial artery with atherectomy.The lesion was crossed with a whisper guide wire and another manufacture¿s guide wire.Atherectomy was performed with a total of two passes.After removal of the atherectomy device, the 2.0x60 armada 14 balloon dilatation catheter (bdc) was used for post dilatation.After inflation, the guide wire was attempted to be exchanged, but met resistance with the bdc.The tip of the guide wire separated; however, remained attached to the tip of the bdc.Once the bdc was removed from the anatomy, the tip of the bdc was noted to be curled with the separated tip of the guide wire inside of it.A new armada 14 was used to successfully complete the procedure.There were no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported tip damage (kink) was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 was unable to determine a conclusive cause for the reported difficulty removing the device from the guide wire; however, the reported tip damage (kink) appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17138434
• Report Number: 2024168-2023-06330
• Device Sequence Number: 11745086
• Product Code: DQY
• UDI-Device Identifier: 08717648155963
• UDI-Public: 08717648155963
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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: 02/28/2026
• Device Model Number: A2020-060
• Device Catalogue Number: A2020-060
• Device Lot Number: 2091341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIPER WIRE
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 78 KG