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

Model Number	A2020-080
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.The ht command es guide wire referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right anterior tibial artery.A ht command es guide wire was advanced to the lesion and a 2.0x80mm armada 14 balloon catheter was advanced over the guide wire without issues.The balloon catheter was removed and an attempt to advance an unspecified 014 laser catheter over the guide wire was made; however, resistance was felt.The guide wire was removed, and a non-abbott guide wire was advanced.The laser catheter was advanced over the non-abbott guide wire without issues and the lesion was lasered.The laser catheter was removed, and the same armada 14 balloon catheter was advanced on the non-abbott guide wire.The non-abbott guide wire was removed, and the balloon catheter was used as an exchange catheter.A new ht command es guide wire was advanced through the balloon catheter and the lesion was dilated.During removal of the guide wire, resistance was felt with the balloon catheter and both were removed as a unit.The procedure was successfully completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 from this lot.The investigation was unable to determine a conclusive cause for the reported resistance.Based on the information reviewed, there is no indication of a product quality issue with respect 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: 9878950
• Report Number: 2024168-2020-02866
• Device Sequence Number: 16998875
• Product Code: DQY
• UDI-Device Identifier: 08717648155970
• UDI-Public: 08717648155970
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 04/20/2020

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: 09/30/2022
• Device Model Number: A2020-080
• Device Catalogue Number: A2020-080
• Device Lot Number: 9041141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/20/2020
• 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
• Patient Age: 79 YR
• Patient Weight: 84