MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERMANENT SLED BAG; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H749393150100
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device sterility was compromised.Following an ultrasound examination involving an ilab imaging system, it was noticed that a small amount of blood was present on the permanent sled because the permanent sled sterile bag had developed a hole under where the catheter was seated.There were no patient complications.

• Brand Name: PERMANENT SLED BAG
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21692155
• Report Number: 2124215-2025-17997
• Device Sequence Number: 15761619
• Product Code: ITX
• UDI-Device Identifier: 08714729896845
• UDI-Public: 08714729896845
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K152403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: H749393150100
• Device Catalogue Number: H749393150100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/25/2025
• 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