MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B1050-040
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
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.The additional absolute device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the proximal left superior femoral artery (psfa) with moderate calcification and none tortuosity.The 6.0x60mm absolute pro self expanding stent system (sess) was advanced and the stent was implanted.After implantation, it was observed that the proximal and distal portions of the stent were not fully deployed.The 5x40mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced for post dilatation.The balloon was inflated once at 12 atmospheres.During removal, resistance was met with the stent struts.Several attempts were needed to remove the device.There were no reported adverse patient sequela 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 difficulty removing the device from the stent could not be replicated in a testing environment as it was based on operational circumstances.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 complaint from this lot.The investigation determined the reported difficulty removing the device from the stent appears to be related to operational context.It was reported by the account that the proximal and distal portions of the absolute pro self-expanding stent were not fully deployed.In this case, it is likely that during post dilatation of the absolute pro stent, interaction with the stent struts likely resulted in the reported difficult to remove.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
Event or Problem Description
Subsequent to the initially filed report, the account stated that the stent was fully deployed in the target lesion.No additional information was provided.

• Brand Name: ARMADA 35 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: 17268942
• Report Number: 2024168-2023-07116
• Device Sequence Number: 14967167
• Product Code: LIT
• UDI-Device Identifier: 08717648154607
• UDI-Public: 08717648154607
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111899
• 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): 08/16/2023

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: B1050-040
• Device Catalogue Number: B1050-040
• Device Lot Number: 20902G1
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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
• Patient Sex: Unknown