MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY Pro; Catheter, Percutaneous

Model Number	8105
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this guiding inner catheter had significant resistance, and when an attempt was made to pull this catheter, a portion sheared off.Showing the section inside the guide had its purple coating stripped down to the braided metal.This guiding catheter was out of service and will be returned for analysis.No adverse patient effects were reported.
Additional Manufacturer Narrative
The accessory was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the accessory, however no product return as of this time.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported that this guiding inner catheter had significant resistance, and when an attempt was made to pull this catheter, a portion sheared off.Showing the section inside the guide had its purple coating stripped down to the braided metal.This guiding catheter was out of service and will be returned for analysis.No adverse patient effects were reported.

• Brand Name: ACUITY Pro
• Common Device Name: Catheter, Percutaneous
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 24443132
• Report Number: 2124215-2026-10387
• Device Sequence Number: 16043403
• Product Code: DQY
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/28/2026

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: 8105
• Device Catalogue Number: 8105
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 04/24/2026; 07/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/09/2026; 05/19/2026; 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 55 YR
• Patient Sex: Unknown