MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ESPRIT¿; SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE

Model Number	1203300-38
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported tip deformation was not confirmed; however, the tip was returned separated which is likely what the account identified as deformation.The reported shaft separation was confirmed.A corrective and preventative actions (capa) review was performed and revealed no indication of a product quality issue.Based on the information provided, a definitive cause for the reported issue could not be determined.The reported tip deformation was not confirmed; however, it is likely the account identified the observed tip separation as deformation.Factors that could contribute to tip separations include, but are not limited to, damage during manufacturing, inadvertent mishandling during unpackaging of the device, sheath/stylet removal, preparation, or during use of the device.The proximal portion of the delivery system was not returned and the account indicated the separation occurred during preparation of the device.Factors that may contribute to material separation (proximal shaft) include, but are not limited to, kinks or bends, inadvertent mishandling, user technique, interaction with difficult anatomy and/or accessory devices.Analysis of the returned device confirmed the reported material separation.In this case, it is possible that mishandling of the device contributed to the reported material separation.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that during preparation of the 3.0x38mm esprit btk system, when removing the protective sheath, the device was compromised.During the attempt to insert the guide wire it was the tip was kinked.The hypotube shaft separated.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ESPRIT¿
• Common Device Name: SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 25578579
• Report Number: 2024168-2026-02469
• Device Sequence Number: 15696925
• Product Code: NXW
• UDI-Device Identifier: 08717648357015
• UDI-Public: (01)08717648357015(11)251120(17)271119(10)5112061
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• 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
• Report Date (Section B): 06/22/2026

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: 1203300-38
• Device Catalogue Number: 1203300-38
• Device Lot Number: 5112061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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