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

Model Number	H749393150100
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device sterility was compromised.The permanent sled sterile bag, a system accessory which was part of an ilab ultrasound imaging system, was selected for use in the ultrasound examination.During preparation, when opening the sled bag, the physician observed that the sticker was not intact and concerned about the sterility when covering the mdu.The procedure was completed using alternate method.There was no patient complications reported.
Event or Problem Description
It was reported that device sterility was compromised.The permanent sled sterile bag, a system accessory which was part of an ilab ultrasound imaging system, was selected for intravascular ultrasound (ivus) examination of the target lesion.During preparation, when opening the sled bag, the physician observed that the sticker was not intact and concerned about the sterility when covering the mdu.The procedure was completed using alternate device.There was no patient complications reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of unable to exclude device problem following a review of the reported event details, available information, and product record review.In this case the device was not returned for product analysis therefore limiting the identification of a most probable cause of the reported event.Improper handling, device manipulation or not following the correct instructions during the procedure, could be contributing factors to the reported issue.However, there is no additional detail pertinent to the event.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24500670
• Report Number: 2124215-2026-11794
• Device Sequence Number: 9870129
• Product Code: ITX
• UDI-Device Identifier: 08714729896845
• UDI-Public: (01)08714729896845(17)281019(10)38257694
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2026

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: H749393150100
• Device Catalogue Number: H749393150100
• Device Lot Number: 0038257694
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/05/2026
• Date Device Manufactured: 10/20/2025
• 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