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

Model Number	F2015-020
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 1.5x20mmx145cm armada 14 over the wire (otw) balloon dilatation catheter (bdc) was being used in a procedure when an unspecified guide wire (gw) perforated the balloon, and it could not properly fill with contrast.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 and/or complaints from this lot.The investigation determined the reported complaint appears to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.D9: device available for evaluation updated from yes to no.
Event or Problem Description
Subsequent to the initially filed report, additional information was received: a 1.5x20mmx145cm armada 14 over the wire (otw) balloon dilatation catheter (bdc) was advanced over a 014 ht winn guide wire (gw) to the target occlusion in the ata.The winn guide wire was then removed so angiography could be performed through the armada balloon.The winn guide wire was then re-advanced, and re-insert through the armada bdc, which was still in the ata, when the wire was inadvertently advanced all the way through the balloon and outside of the balloon.The bdc would not be able to properly fill with contrast and was removed from the anatomy.A 2x120mmx150cm armada14 bdc was used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

• Brand Name: ARMADA 14 XT 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 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: 16969154
• Report Number: 2024168-2023-05340
• Device Sequence Number: 5580657
• Product Code: LOX
• UDI-Device Identifier: 08717648182884
• UDI-Public: 08717648182884
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/31/2023

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: 10/31/2024
• Device Model Number: F2015-020
• Device Catalogue Number: F2015-020
• Device Lot Number: 11109G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Male