MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00558880
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1: initial reporter phone: (b)(6).Reported here as the physician phone number exceeded character limit for the designated field.Block h6: imdrf device code a0501 captures the reportable event of rx tunnel detachment.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the esophagus during a gastroscopy with dilatation procedure to treat stricture performed on (b)(6) 2025.During the procedure, advancing the catheter was initially difficult, but the process eventually went well.Dilatation was performed, and when switching to a larger dilation balloon, the physician noticed that a component (the black cover) was missing from the balloon.The scope was changed, and the procedure was completed using another gastroscope and a larger dilation balloon.Later, the missing black cover was found inside the first gastroscope.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1: initial reporter phone: (b)(6), reported here as the physician phone number exceeded character limit for the designated field.Block h6: imdrf device code a0501 captures the reportable event of rx tunnel detachment.:the returned cre rx dilatation balloon was analyzed, and a visual inspection found that only the rx tunnel was returned.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of rx tunnel detachment was not confirmed.It was noted that only the rx tunnel was returned consequently, further in-depth evaluation was not possible, to determine whether the device was difficult to advance, and the rx tunnel was detached and if it was attributable to physician manipulation or procedural technique, or to a device-related problem.Therefore, the most probable root cause could not be established.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the esophagus during a gastroscopy with dilatation procedure to treat stricture performed on (b)(6) 2025.During the procedure, advancing the catheter was initially difficult, but the process eventually went well.Dilatation was performed, and when switching to a larger dilation balloon, the physician noticed that a component (the black cover) was missing from the balloon.The scope was changed, and the procedure was completed using another gastroscope and a larger dilation balloon.Later, the missing black cover was found inside the first gastroscope.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: CRE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23770133
• Report Number: 3005099803-2025-06658
• Device Sequence Number: 9750647
• Product Code: FGE
• UDI-Device Identifier: 08714729965435
• UDI-Public: (01)08714729965435
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K172520
• 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): 01/27/2026

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: M00558880
• Device Catalogue Number: M00558880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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 Sex: Unknown