MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MDU5 PLUS STERILE BAG; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	H749MDU5PLUSBAG0
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device issue occurred.An mdu plus sterile bag was used as part of the ilab ultrasound imaging system for an intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the physician attempted to connect the ivus catheter to the motordrive unit (mdu), but it kept disconnecting.The screen displayed an error, and the physician could not complete the run.As a result, the mdu plus sterile bag became unsterile.The procedure was completed successfully, and no patient complications were reported.
Event or Problem Description
It was reported that a device issue occurred.An mdu plus sterile bag was used as part of the ilab ultrasound imaging system for an intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the physician attempted to connect the ivus catheter to the motordrive unit (mdu), but it kept disconnecting.The screen displayed an error, and the physician could not complete the run.As a result, the mdu plus sterile bag became unsterile.The procedure was completed successfully, and no patient complications were reported.It was further reported that the device became unsterile due to the bag tearing after repeated back-and-forth manipulation of the catheter.
Additional Manufacturer Narrative
H6 device codes: corrected.

• Brand Name: MDU5 PLUS STERILE BAG
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• 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: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20621942
• Report Number: 2124215-2024-69591
• Device Sequence Number: 8756280
• Product Code: IYO
• UDI-Device Identifier: 08714729842255
• UDI-Public: 08714729842255
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: H749MDU5PLUSBAG0
• Device Catalogue Number: H749MDU5PLUSBAG0
• Device Lot Number: 0034414389
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/19/2024
• Date Device Manufactured: 12/14/2023
• 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