MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY Whisper View¿; WIRE, GUIDE, CATHETER

Model Number	4648
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction

• Brand Name: ACUITY Whisper View¿
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; saint paul MN 55112
• MDR Report Key: 50896737
• Report Number: 50896737
• Device Sequence Number: 5903549
• Product Code: DQX
• UDI-Device Identifier: 00802526512988
• UDI-Public: (01)00802526512988
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/17/2026
• Report Date (Section F): 08/17/2026

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: 4648
• Device Lot Number: 39350447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 152 LB
• Date Report Sent to FDA: 08/17/2026