MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	F2020-020
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
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.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure performed was to treat a heavily calcified, mildly tortuous dorsalis pedis artery.A hi-torque command guidewire was removed from the patient and backloaded into the 2.0x20mm armada 14 balloon dilatation catheter (bdc); however, the guidewire became stuck.The guide wire could not advance forward nor backwards and both devices were removed together as a single unit through the sheath.A bow on the distal tip and shaft of the armada bdc was observed.The procedure was aborted.There was no reported adverse patient effects 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 kinks and separation were confirmed.The reported difficulty advancing and removing the device could not be replicated in a testing environment due to the condition of the returned device.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.The complaint information and analysis of the returned device were reviewed.The distal segment of the tip material and distal balloon marker were not returned.Follow up was performed with the account and they confirmed nothing was left in the patient anatomy.Possible factors that may contribute to the difficult advancing and removing the bdc from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, buildup of procedural contaminants in the guide wire lumen, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the shaft of the catheter.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported difficulty advancing the device onto the guide wire and removing the device from the guide wire could not be determined; however, the reported kinks and separation appear to be related to circumstances of the procedure.Possible factors that may contribute to the difficult advancing and removing the bdc from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, buildup of procedural contaminants in the guide wire lumen, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the shaft of the catheter.In this case, a conclusive cause for the reported complaints cannot be determined.Additionally, it is likely that the reported kink damage and tip separation resulted from manipulation of the devices as difficulty was encountered.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 1562 added.
Event or Problem Description
Subsequently, it was reported that the tip of the armada 14 balloon dilatation catheter was separated during the procedure.No additional information was provided.

• Brand Name: ARMADA
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20905713
• Report Number: 2024168-2024-14567
• Device Sequence Number: 14445222
• Product Code: LIT
• UDI-Device Identifier: 08717648182938
• UDI-Public: (01)08717648182938(17)270531(10)40619G1
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K121352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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 Model Number: F2020-020
• Device Catalogue Number: F2020-020
• Device Lot Number: 40619G1
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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: BDC: ARMADA & GUIDEWIRE: HT COMMAND
• Patient Sex: Unknown